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49 regimens on this page 82 variants on this page

Adjuvant chemotherapy

Fluorouracil & Leucovorin

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Regimen

Study	Evidence	Comparator
Neoptolemos et al. 2004	Phase III	5-FU & RT Observation
Neoptolemos et al. 2010 (ESPAC-3)	Phase III	Gemcitabine

Chemotherapy

Fluorouracil (5-FU) 425 mg/m² IV bolus once per day on days 1 to 5, given second
Folinic acid (Leucovorin) 20 mg/m² IV bolus once per day on days 1 to 5, given first

28-day cycle for 6 cycles

References

Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. link to original article contains verified protocol PubMed
Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar)

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Regimen

Study	Evidence	Comparator
Oettle et al. 2007 (CONKO-001)	Phase III	Observation
Neoptolemos et al. 2010 (ESPAC-3)	Phase III	Fluorouracil & Leucovorin

Treatment starts day 10 to 42 after surgery or after wound is healed.

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15

28-day cycle for 6 cycles

References

Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. link to original article contains verified protocol PubMed
1. Update: Abstract: P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. link to abstract
Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. link to original article contains verified protocol PubMed

Placebo (Observation)

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Regimen

Study	Evidence	Comparator
Neoptolemos et al. 2004	Phase III	Fluorouracil & Leucovorin
Oettle et al. 2007 (CONKO-001)	Phase III	Gemcitabine

No active antineoplastic treatment. Placed here because one or more randomized clinical trials included a placebo arm in this disease context.

References

Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. link to original article contains verified protocol PubMed
Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. link to original article contains verified protocol PubMed
1. Update: Abstract: P. Neuhaus, H. Riess, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zuelke, J. Fahlke, J. Langrehr, H. Oettle. CONKO-001: Final results of the randomized, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine versus observation in patients with resected pancreatic cancer (PC). 2008 ASCO Annual Meeting abstract LBA4504. link to abstract

Adjuvant chemoradiation

Fluorouracil (5-FU) & RT

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Regimen

Study	Evidence	Comparator
Neoptolemos et al. 2004	Phase III	Fluorouracil & Leucovorin Observation
Regine et al. 2008	Phase III	Gemcitabine -> Fluorouracil & RT -> Gemcitabine

Chemotherapy

Fluorouracil (5-FU) 250 mg/m²/day IV continuous infusion on days 1 to 21

21-day course, followed in 1 to 2 weeks by:

Chemoradiotherapy

Fluorouracil (5-FU) 250 mg/m²/day IV continuous infusion throughout radiation therapy
Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.

6-week course, followed in 3 to 5 weeks by:

Chemotherapy

Fluorouracil (5-FU) 250 mg/m²/day IV continuous infusion on days 1 to 28

6-week cycle for 2 cycles

References

Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. link to original article contains verified protocol PubMed
Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. link to original article contains verified protocol PubMed

Gemcitabine -> Fluorouracil & RT -> Gemcitabine

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RT: Radiation Therapy

Regimen

Study	Evidence	Comparator
Regine et al. 2008	Phase III	Fluorouracil & RT

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15

21-day course, followed in 1 to 2 weeks by:

Chemoradiotherapy

Fluorouracil (5-FU) 250 mg/m²/day IV continuous infusion throughout radiation therapy
Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.

6-week course, followed in 3 to 5 weeks by:

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15

28-day cycle for 3 cycles

References

Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. link to original article contains verified protocol PubMed

Neoadjuvant chemoradiation

Cetuximab, Gemcitabine, RT

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Regimen

Study	Evidence
Pipas et al. 2012	Phase II

Chemoradiotherapy

Cetuximab (Erbitux) as follows:
- 6 to 8 days prior radiation: 400 mg/m² IV over 120 minutes once
- During radiation: 250 mg/m² over 60 minutes once per week for 6 doses
Gemcitabine (Gemzar) 50 mg/m² IV over 30 minutes twice per week for 12 doses
- Given Monday/Thursday or Tuesday/Friday. Infusion completed ½ to 2 hours prior to RT.
Concurrent radiation therapy, delivered using IMRT. Gross tumor volume (GTV) was all known disease including imaging proven nodal disease. The primary planning target volume (PTV1) included the GTV with 2- to 3-cm margins in all directions as well as potential nodal involvement. Secondary planning target volume (PTV2) included the GTV with 1- to 1.5-cm margins on all sides including proven nodal involvement. Tertiary planning treatment volume (PTV3) included the area of the GTV adjacent to the vascular structures specifically the mesenteric and portal vessels with a 0.5-cm margin. The prescription dose delivered to PTV3 was 54 Gy in 28 fractions. Synchronously, PTV1 and PTV2 received 45 and 50.4 Gy, respectively. All fields were treated daily at five fractions per week.

Supportive medications

GI prophylaxis with a proton pump inhibitor during chemoradiotherapy

6-week course

One month following therapy, patients were restaged with CT scan of chest/abdomen/pelvis. Patients deemed to be candidates for surgical resection were offered laparotomy ∼6to 10 weeks after completion of neoadjuvant therapy.

References

Pipas JM, Zaki BI, McGowan MM, Tsapakos MJ, Ripple GH, Suriawinata AA, Tsongalis GJ, Colacchio TA, Gordon SR, Sutton JE, Srivastava A, Smith KD, Gardner TB, Korc M, Davis TH, Preis M, Tarczewski SM, Mackenzie TA, Barth RJ Jr. Neoadjuvant cetuximab, twice-weekly gemcitabine, and intensity-modulated radiotherapy (IMRT) in patients with pancreatic adenocarcinoma. Ann Oncol. 2012 Nov;23(11):2820-7. Epub 2012 May 9. link to original article contains verified protocol PubMed

Docetaxel, Gemcitabine, RT

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Regimen

Study	Evidence
Pipas et al. 2005	Phase II

Chemotherapy

Docetaxel (Taxotere) 65 mg/m² IV over 60 minutes once per day on days 1, 15, 29
Gemcitabine (Gemzar) 4000 mg/m² IV over 30 minutes once per day on days 1, 15, 29

6-week course, followed immediately (day 43) by:

Chemoradiation

Gemcitabine (Gemzar) 50 mg/m² IV over 30 minutes twice per week for 12 doses
- Given Monday/Thursday or Tuesday/Friday. Infusion completed ½ to 2 hours prior to RT.
Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, for a total dose of 45 Gy to primary target volume. Then 5.4 Gy boost to secondary target volume of 1- to 1.5-cm margin on all sides, including proven nodal involvement. Total 50.4 Gy in 28 fractions.

Supportive medications

GI prophylaxis with a proton pump inhibitor during chemoradiotherapy

6-week course

References

Pipas JM, Barth RJ Jr, Zaki B, Tsapakos MJ, Suriawinata AA, Bettmann MA, Cates JM, Ripple GH, Sutton JE, Gordon SR, McDonnell CE, Perez RP, Redfield N, Meyer LP, Marshall JF, Cole BF, Colacchio TA. Docetaxel/Gemcitabine followed by gemcitabine and external beam radiotherapy in patients with pancreatic adenocarcinoma. Ann Surg Oncol. 2005 Dec;12(12):995-1004. Epub 2005 Nov 1. link to original article contains verified protocol PubMed

Gemcitabine & RT

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Regimen 1

Study	Evidence
Takahashi et al. 2013	Phase II

Chemoradiotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV once per day on days 1, 8, 15
Concurrent radiation therapy, 2 Gy per fraction, 5 days per week, 25 fractions, total dose of 50 Gy over 5 weeks.

4-week cycle for 3 cycles

Restaging is performed 8 weeks after radiation complete (2 weeks after chemotherapy complete). Resection immediately thereafter, if feasible.

Regimen 2

Study	Evidence
Landry et al. 2010	Phase II

Chemoradiotherapy

Gemcitabine (Gemzar) 500 mg/m² IV over 50 minutes once per week for 6 weeks
Concurrent radiation therapy, 180 cGy x 22 with 3 cm margin to GTV then 180 cGy x 6 with 2 cm margin to GTV, total 50.4 Gy over 6 weeks

Restaging after radiation complete. 4 to 6 week break, followed by surgery, followed by 4 to 8 week break. Then adjuvant chemotherapy:

Adjuvant chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 100 minutes once per day on days 1 & 8

21-day cycle for 5 cycles

References

Landry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010 Jun 1;101(7):587-92. link to original article contains verified protocol PubMed
Takahashi H, Ohigashi H, Gotoh K, Marubashi S, Yamada T, Murata M, Ioka T, Uehara H, Yano M, Ishikawa O. Preoperative gemcitabine-based chemoradiation therapy for resectable and borderline resectable pancreatic cancer. Ann Surg. 2013 Dec;258(6):1040-50.link to original article contains verified protocol PubMed

mFOLFIRINOX, Gemcitabine, RT

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Regimen #1

Study	Evidence
Blazer et al. 2015	Retrospective

Modified FOLFIRINOX portion

Irinotecan (Camptosar) 165 mg/m² IV over 90 minutes once on day 1
Oxaliplatin (Eloxatin) 85 mg/m² IV over 2 to 4 hours once on day 1
Fluorouracil (5-FU) 2400 mg/m² IV continuous infusion for 46 h on days 1 to 3

Supportive medications

Pegfilgrastim (Neulasta) 6 mg SC once on day 4

2-week cycle for 4 to 8 cycles

Followed by complete restaging. If tumor localized but still not resectable, chemoradiotherapy was administered:

Chemoradiotherapy

Gemcitabine (Gemzar) 1000 mg/m²/week concurrent with radiation
Radiation was 36 Gy in 15 daily fractions

Regimen #2

Study	Evidence
Hosein et al. 2012	Retrospective

FOLFIRINOX portion

Irinotecan (Camptosar) 180 mg/m² IV once on day 1
Oxaliplatin (Eloxatin) 85 mg/m² IV once on day 1
Folinic acid (Leucovorin) 400mg/m² IV once on day 1
Fluorouracil (5-FU) 400mg/m² IV bolus on day 1
Fluorouracil (5-FU) 2400 mg/m² IV continuous infusion for 46 hours on days 1 to 3

Cycles repeated every 2 weeks. Protocol followed "per ACCORD-11 trial"

Treatment stopped at maximum response or tolerability. Resectable patients by imaging criteria were offered surgery, followed by postoperative chemoradiotherapy. Unresectable patients were offered chemoradiotherapy, followed by surgery (if they became resectable):

Chemoradiotherapy

Gemcitabine (Gemzar) 600 mg/m²/week
Radiation at 50.4 Gy in 28 fractions.

References

Retrospective: Hosein PJ, Macintyre J, Kawamura C, Maldonado JC, Ernani V, Loaiza-Bonilla A, Narayanan G, Ribeiro A, Portelance L, Merchan JR, Levi JU, Rocha-Lima CM. A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma. BMC Cancer. 2012 May 29;12:199. link to original article PubMed
Retrospective: Blazer M, Wu C, Goldberg RM, Phillips G, Schmidt C, Muscarella P, Wuthrick E, Williams TM, Reardon J, Christopher Ellison E, Bloomston M, Bekaii-Saab T. Neoadjuvant Modified (m) FOLFIRINOX for Locally Advanced Unresectable (LAPC) and Borderline Resectable (BRPC) Adenocarcinoma of the Pancreas. Ann Surg Oncol. 2015 Apr;22(4):1153-9. link to original article PubMed

Locally advanced disease (unresectable)

Gemcitabine & RT

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Regimen #1 (600 mg/m²)

Study	Evidence	Comparator
Cardenes et al. 2011	Phase II
Loehrer et al. 2011	Phase III	Gemcitabine

Chemoradiotherapy

Gemcitabine (Gemzar) 600 mg/m² IV over 30 to 60 minutes once per week during radiation
Concurrent radiation therapy, 1.8 Gy per fraction, 5 days per week, 28 fractions, total dose of 50.4 Gy over 5.5 weeks.

One course, followed in 4 weeks by:

Maintenance chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per week, 3 out of 4 weeks

28-day cycle for 5 cycles or until disease progression

Regimen #2 (400 mg/m²)

Study	Evidence
Epelbaum et al. 2002	Phase II

Chemotherapy

Gemcitabine (Gemzar) 1000mg/m² IV over 30 minutes once per week for 7 weeks

Radiation planning during this phase, followed by:

Chemoradiotherapy

Gemcitabine (Gemzar) 400 mg/m² IV over 30 minutes once per week (days 1, 8, 15)
Concurrent radiation therapy, 5 days per week, 28 fractions, total dose of 50.4 Gy over 5.5 weeks

28 day cycle for 2 cycles (completion of radiation), followed by:

Maintenance chemotherapy

Gemcitabine (Gemzar) 1000mg/m² IV over 30 minutes once per week, 3 out of 4 weeks

28-day cycles until disease progression

References

Epelbaum R, Rosenblatt E, Nasrallah S, Faraggi D, Gaitini D, Mizrahi S, Kuten A. Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer. J Surg Oncol. 2002 Nov;81(3):138-43. link to original article contains verified protocol PubMed
Cardenes HR, Moore AM, Johnson CS, Yu M, Helft P, Chiorean EG, Vinson J, Howard TJ, Stephens AW, Tai DF, Loehrer PJ Sr. A phase II study of gemcitabine in combination with radiation therapy in patients with localized, unresectable, pancreatic cancer: a Hoosier Oncology Group study. Am J Clin Oncol. 2011 Oct;34(5):460-5.link to original article PubMed
Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. link to original article contains verified protocol PubMed

Metastatic disease

Best supportive care

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Regimen

Study	Evidence	Comparator
Pelzer et al. 2011 (CONKO-003)	Phase III	OFF

Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.

References

Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676-81. Epub 2011 May 10. link to original article contains verified protocol--with error as noted above PubMed

Capecitabine (Xeloda)

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Regimen

Study	Evidence
Cartwright et al. 2002	Phase II

Chemotherapy

Capecitabine (Xeloda) 1250 mg/m² PO BID on days 1 to 14

21-day cycle for up to 1 year

References

Cartwright TH, Cohn A, Varkey JA, Chen YM, Szatrowski TP, Cox JV, Schulz JJ. Phase II study of oral capecitabine in patients with advanced or metastatic pancreatic cancer. J Clin Oncol. 2002 Jan 1;20(1):160-4. link to original article contains verified protocol PubMed

Capecitabine & Erlotinib

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Regimen

Study	Evidence
Kulke et al. 2007	Phase II

Chemotherapy

Capecitabine (Xeloda) 1000 mg/m² (rounded to the nearest 150 mg tablet) PO BID on days 1 to 14
Erlotinib (Tarceva) 150 mg PO on days 1 to 21

21-day cycles, given until progression of disease or unacceptable toxicity

References

Kulke MH, Blaszkowsky LS, Ryan DP, Clark JW, Meyerhardt JA, Zhu AX, Enzinger PC, Kwak EL, Muzikansky A, Lawrence C, Fuchs CS. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol. 2007 Oct 20;25(30):4787-92. link to original article contains verified protocol PubMed

Cisplatin & Gemcitabine

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Regimen

Study	Evidence	Comparator
Heinemann et al. 2006	Phase III	Gemcitabine

Chemotherapy

Cisplatin (Platinol) 50 mg/m² IV over 1 hour once per day on days 1 & 15
Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1 & 15

28-day cycles

References

Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. link to original article contains verified regimen PubMed

Erlotinib & Gemcitabine

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Regimen

Study	Evidence	Comparator
Moore et al. 2007	Phase III	Gemcitabine

Initial chemotherapy

Erlotinib (Tarceva) 100 or 150 mg (100 mg dose recommended) PO once per day
Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43

8-week course, followed by:

Maintenance chemotherapy

Erlotinib (Tarceva) 100 or 150 mg (100 mg dose recommended) PO once per day
Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15

4-week cycles

References

Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. link to original article contains verified protocol PubMed

Fluorouracil (5-FU)

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Regimen

Study	Evidence	Comparator
Burris et al. 1997	Phase III	Gemcitabine

Inferior to gemcitabine. Here for reference purposes, only.

References

Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. link to original article contains verified protocol PubMed

FOLFIRINOX

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FOLFIRINOX: FOLinic acid, Fluorouracil, IRINotecan, OXaliplatin

Regimen

Study	Evidence	Comparator
Conroy et al. 2011	Phase III	Gemcitabine

Chemotherapy

Folinic acid (Leucovorin) 400 mg/m² IV over 2 hours once on day 1; given second
Fluorouracil (5-FU) 400 mg/m² IV bolus, then 1200 mg/m²/day (total dose of 2400 mg/m²) IV continuous 46-hour infusion on days 1 to 2; given last
Irinotecan (Camptosar) 180 mg/m² IV over 90 minutes once on day 1; given third together with the last 90 minutes of leucovorin; that is, irinotecan starts 30 minutes after the start of leucovorin
Oxaliplatin (Eloxatin) 85 mg/m² IV over 2 hours once on day 1, given first

14-day cycles

References

Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar)

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Regimen #1

Study	Evidence	Comparator
Burris et al. 1997	Phase III	5-FU
Moore et al. 2007	Phase III	Erlotinib & Gemcitabine
Herrmann et al. 2007	Phase III	GemCap
Poplin et al. 2009 (E6201)	Phase III	GEM FDR GEMOX
Cunningham et al. 2009	Phase III	GEM-CAP
Conroy et al. 2011	Phase III	FOLFIRINOX
Loehrer et al. 2011	Phase III	Gemcitabine & Radiation
Von Hoff et al. 2013 (MPACT)	Phase III	Gemcitabine & nab-Paclitaxel

Initial chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43

8-week course, followed by:

Maintenance chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15; in Burris et al. 1997, patients with grade 2 or lower toxicities could have had doses increased to 1250 mg/m²

4-week cycles

Regimen #2

Study	Evidence	Comparator
Heinemann et al. 2006	Phase III	Gemcitabine & Cisplatin

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15

4-week cycles

Regimen #3, Fixed-dose rate (FDR)

Study	Evidence	Comparator
Poplin et al. 2009 (E6201)	Phase III	Gemcitabine GEMOX

Chemotherapy

Gemcitabine (Gemzar) 1500 mg/m² IV over 150 minutes (10 mg/m²/min) once per day on days 1, 8, 15

28-day cycles

References

Burris HA 3rd, Moore MJ, Andersen J, Green MR, Rothenberg ML, Modiano MR, Cripps MC, Portenoy RK, Storniolo AM, Tarassoff P, Nelson R, Dorr FA, Stephens CD, Von Hoff DD. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997 Jun;15(6):2403-13. link to original article contains verified protocol PubMed
Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. link to original article contains verified protocol PubMed
Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. link to original article contains verified regimen PubMed
Moore MJ, Goldstein D, Hamm J, Figer A, Hecht JR, Gallinger S, Au HJ, Murawa P, Walde D, Wolff RA, Campos D, Lim R, Ding K, Clark G, Voskoglou-Nomikos T, Ptasynski M, Parulekar W; National Cancer Institute of Canada Clinical Trials Group. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 May 20;25(15):1960-6. Epub 2007 Apr 23. link to original article contains verified protocol PubMed
Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. link to original article contains verified protocol PubMed
Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. link to original article contains verified protocol PubMed
Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. link to original article contains verified protocol PubMed
Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. link to original article contains verified protocol PubMed
Conroy T, Desseigne F, Ychou M, Bouché O, Guimbaud R, Bécouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardière C, Bennouna J, Bachet JB, Khemissa-Akouz F, Péré-Vergé D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. link to original article contains verified protocol PubMed
Loehrer PJ Sr, Feng Y, Cardenes H, Wagner L, Brell JM, Cella D, Flynn P, Ramanathan RK, Crane CH, Alberts SR, Benson AB 3rd. Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: an Eastern Cooperative Oncology Group trial. J Clin Oncol. 2011 Nov 1;29(31):4105-12. Epub 2011 Oct 3. link to original article contains verified protocol PubMed
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. Epub 2013 Oct 16. link to original article contains verified protocol PubMed

GemCap, GEM-CAP

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GemCap/GEM-CAP: Gemcitabine, Capecitabine

Regimen #1

Study	Evidence	Comparator
Cunningham et al. 2009	Phase III	Gemcitabine

Initial chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
Capecitabine (Xeloda) 830 mg/m² PO BID on days 1 to 21, 29 to 49

8-week course, THEN

Maintenance chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1, 8, 15
Capecitabine (Xeloda) 830 mg/m² PO BID on days 1 to 21

4-week cycles, given until progression of disease or unacceptable toxicity

Regimen #2

Study	Evidence	Comparator
Herrmann et al. 2007	Phase III	Gemcitabine
Bernhard et al. 2008 (SAKK 44/00-CECOG/PAN.1.3.001)	Phase III	Gemcitabine

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 30 minutes once per day on days 1 & 8
Capecitabine (Xeloda) 650 mg/m² PO BID on days 1 to 14

21-day cycle for up to 24 weeks

References

Herrmann R, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi B, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Cina S, Bernhard J, Dietrich D, Scheithauer W; Swiss Group for Clinical Cancer Research; Central European Cooperative Oncology Group. Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol. 2007 Jun 1;25(16):2212-7. link to original article contains verified protocol PubMed
Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. link to original article contains verified protocol PubMed
Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. link to original article contains verified protocol PubMed

GemOx

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GemOx: Gemcitabine, Oxaliplatin

Regimen

Study	Evidence	Comparator
Louvet et al. 2005	Phase III	Gemcitabine
Poplin et al. 2009 (E6201)	Phase III	Gemcitabine Gemcitabine, FDR

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV over 100 minutes once on day 1
Oxaliplatin (Eloxatin) 100 mg/m² IV over 2 hours once on day 2

14-day cycles

References

Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. link to original article contains verified protocol PubMed
Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. Epub 2009 Jul 6. link to original article contains verified protocol PubMed

Gemcitabine & nab-Paclitaxel

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Regimen #1

Study	Evidence	Comparator
Von Hoff et al. 2013 (MPACT)	Phase III	Gemcitabine

Chemotherapy

Gemcitabine (Gemzar) as follows (given second):
- Cycle 1: 1000 mg/m² IV once per day on days 1, 8, 15, 29, 36, 43
- Cycle 2 onwards: 1000 mg/m² IV once per day on days 1, 8, 15
Paclitaxel, nanoparticle albumin-bound (Abraxane) as follows (given first):
- Cycle 1: 125 mg/m² IV over 30 to 40 minutes once per day on days 1, 8, 15, 29, 36, 43
- Cycle 2 onwards: 125 mg/m² IV over 30 to 40 minutes once per day on days 1, 8, 15

8-week cycle followed by 28-day cycles until disease progression or intolerance

Regimen #2

Study	Evidence
Von Hoff et al. 2011	Phase II

Note: The abstract and body of Von Hoff et al. 2011 contradicted each other about which drug is given first in this regimen.

Chemotherapy

Gemcitabine (Gemzar) 1000 mg/m² IV once per day on days 1, 8, 15
Paclitaxel, nanoparticle albumin-bound (Abraxane) 100 or 125 mg/m² IV once per day on days 1, 8, 15

28-day cycles

References

Von Hoff DD, Ramanathan RK, Borad MJ, Laheru DA, Smith LS, Wood TE, Korn RL, Desai N, Trieu V, Iglesias JL, Zhang H, Soon-Shiong P, Shi T, Rajeshkumar NV, Maitra A, Hidalgo M. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial. J Clin Oncol. 2011 Dec 1;29(34):4548-54. Epub 2011 Oct 3. link to original article contains verified protocol PubMed
Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. Epub 2013 Oct 16. link to original article contains verified protocol PubMed

GTX

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GTX: Gemcitabine, Taxotere (Docetaxel), Xeloda (Capecitabine)

Regimen

Level of Evidence: Phase II

Note: De Jesus-Acosta et al. 2012 lists the capecitabine dose as "750 mg/m²/day orally divided into two doses," but this is believed to be a typographical error since the original reference that it cites, Fine et al. 2008, uses capecitabine at 750 mg/m² PO BID. The 2009 ASCO abstract by Fine also lists this 750 mg/m² PO BID (1500 mg/m²/day) dose.

Chemotherapy

Gemcitabine (Gemzar) 750 mg/m² IV over 75 minutes once per day on days 4 & 11
Docetaxel (Taxotere) 30 mg/m² IV once per day on days 4 & 11
Capecitabine (Xeloda) 750 mg/m² PO BID on days 1 to 14

21-day cycles, given until progression of disease or unacceptable toxicity

References

Fine RL, Fogelman DR, Schreibman SM, Desai M, Sherman W, Strauss J, Guba S, Andrade R, Chabot J. The gemcitabine, docetaxel, and capecitabine (GTX) regimen for metastatic pancreatic cancer: a retrospective analysis. Cancer Chemother Pharmacol. 2008 Jan;61(1):167-75. Epub 2007 Apr 18. link to original article contains protocol PubMed
R. L. Fine, G. Moorer, W. Sherman, K. Chu, M. Maurer, J. Chabot, I. Postolov, J. Prowda, S. Schreibman, J. Levitz. Phase II trial of GTX chemotherapy in metastatic pancreatic cancer. 2009 ASCO Annual Meeting abstract 4623. link to abstract content property of HemOnc.org
De Jesus-Acosta A, Oliver GR, Blackford A, Kinsman K, Flores EI, Wilfong LS, Zheng L, Donehower RC, Cosgrove D, Laheru D, Le DT, Chung K, Diaz LA Jr. A multicenter analysis of GTX chemotherapy in patients with locally advanced and metastatic pancreatic adenocarcinoma. Cancer Chemother Pharmacol. 2012 Feb;69(2):415-24. Epub 2011 Jul 29. link to original article contains verified protocol--with error as noted above PubMed

OFF

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OFF: Oxaliplatin, Fluorouracil, Folinic acid

Regimen

Study	Evidence	Comparator
Pelzer et al. 2011 (CONKO-003)	Phase III	Best supportive care

Note: The treatment section of Pelzer et al. 2011 incorrectly lists the oxaliplatin dose as "0.85 g/m²," or 850 mg/m².

Chemotherapy

Oxaliplatin (Eloxatin) 85 mg/m² IV over 2 to 4 hours once per day on days 8 & 22
Fluorouracil (5-FU) 2000 mg/m² IV continuous 24-hour infusion on days 1, 8, 15, 22
Folinic acid (Leucovorin) 200 mg/m² IV over 30 minutes once per day on days 1, 8, 15, 22

42-day cycles

References

Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676-81. Epub 2011 May 10. link to original article contains verified protocol--with error as noted above PubMed

Paclitaxel, nanoparticle albumin-bound (Abraxane)

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Regimen

Study	Evidence
Hosein et al. 2013	Phase II

Chemotherapy

Paclitaxel, nanoparticle albumin-bound (Abraxane) 100 mg/m² IV over 30 minutes once per day on days 1, 8, 15

28-day cycles

References

Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. Epub 2012 Feb 2. link to original article contains protocol PubMed

XELOX; CapeOx

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XELOX: XELoda (Capecitabine), OXaliplatin
CapeOX: Capecitabine, OXaliplatin

Regimen

Study	Evidence
Xiong et al. 2008	Phase II

Chemotherapy

Capecitabine (Xeloda) as follows:
- Age <65 years old and ECOG performance status <2: 1000 mg/m² PO BID on days 1 to 14
- Age >65 years old and/or ECOG performance status >=2: 750 mg/m² PO BID on days 1 to 14
Oxaliplatin (Eloxatin) as follows:
- Age <65 years old and ECOG performance status <2: 130 mg/m² IV over 2 hours once on day 1
- Age >65 years old and/or ECOG performance status >=2: 110 mg/m² IV over 2 hours once on day 1

21-day cycles

References

Xiong HQ, Varadhachary GR, Blais JC, Hess KR, Abbruzzese JL, Wolff RA. Phase 2 trial of oxaliplatin plus capecitabine (XELOX) as second-line therapy for patients with advanced pancreatic cancer. Cancer. 2008 Oct 15;113(8):2046-52. link to original article contains verified protocol PubMed

@@ Line 1: / Line 1: @@
 '''Use of this site is subject to you reading and agreeing with the terms set forth in the [[HemOnc.org_-_A_Hematology_Oncology_Wiki:General_disclaimer|disclaimer]].'''
-Is there a regimen missing from this list?  Would you like to share a different dosage/schedule or an additional reference for a regimen?  Have you noticed an error?  Do you have an idea that will help the site grow to better meet your needs and the needs of many others?  You are [[How_to_contribute|invited to contribute to the site]].
+Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are [[How_to_contribute|invited to contribute to the site]].
 {| class="wikitable" style="float:right; margin-right: 5px;"
 |-
-|<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Regimen |limit=10000|format=sum}} regimens on this page</b></font></div>
+|<div style="background-color: #66FF66; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} regimens on this page</b></font></div>
-<div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} variants on this page</b></font></div>
+<div style="background-color: #66CCFF; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} variants on this page</b></font></div>
 |}
 {{TOC limit|limit=3}}
@@ Line 30: / Line 30: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#Fluorouracil_.285-FU.29_.26_RT|5-FU & RT]]<br> [[Pancreatic_cancer#Placebo_.28Observation.29|Observation]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jama.ama-assn.org/content/304/10/1073.long Neoptolemos et al. 2010 (ESPAC-3)]
@@ Line 43: / Line 41: @@
 |-
 |}
+====Chemotherapy====
+*[[Fluorouracil (5-FU)]] 425 mg/m<sup>2</sup> IV bolus once per day on days 1 to 5, '''given second'''
+*[[Folinic acid (Leucovorin)]] 20 mg/m<sup>2</sup> IV bolus once per day on days 1 to 5, '''given first'''
-*[[Fluorouracil (5-FU)]] 425 mg/m2 IV bolus once per day on days 1 to 5, '''given second'''
+'''28-day cycle for 6 cycles'''
-*[[Folinic acid (Leucovorin)]] 20 mg/m2 IV bolus once per day on days 1 to 5, '''given first'''
-'''28-day cycle x 6 cycles'''
 ===References===
@@ Line 72: / Line 70: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#Placebo_.28Observation.29|Observation]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jama.ama-assn.org/content/304/10/1073.long Neoptolemos et al. 2010 (ESPAC-3)]
@@ Line 87: / Line 83: @@
 ''Treatment starts day 10 to 42 after surgery or after wound is healed.''
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
+'''28-day cycle for 6 cycles'''
-'''28-day cycle x 6 cycles'''
 ===References===
@@ Line 129: / Line 125: @@
 |}
-''No active antineoplastic treatment.  Placed here because one or more randomized clinical trials included a placebo arm in this disease context.''
+''No active antineoplastic treatment. Placed here because one or more randomized clinical trials included a placebo arm in this disease context.''
 ===References===
@@ Line 156: / Line 152: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#Fluorouracil_.26_Leucovorin|Fluorouracil & Leucovorin]]<br> [[Pancreatic_cancer#Placebo_.28Observation.29|Observation]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jama.ama-assn.org/content/299/9/1019.long Regine et al. 2008]
@@ Line 169: / Line 163: @@
 |-
 |}
+====Chemotherapy====
+*[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion on days 1 to 21
-Prior to chemoradiation:
+'''21-day course, followed in 1 to 2 weeks by:'''
-*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion on days 1 to 21
-'''21-day course'''
-Chemoradiation:
+====Chemoradiotherapy====
-*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion throughout radiation therapy
+*[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion throughout radiation therapy
-*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.  The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
+*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
-'''6-week course, to start 1 to 2 weeks after chemotherapy'''
+'''6-week course, followed in 3 to 5 weeks by:'''
-After chemoradiation:
+====Chemotherapy====
-*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion on days 1 to 28
+*[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion on days 1 to 28
-'''6-week cycle x 2 cycles, to start 3 to 5 weeks after completion of chemoradiation'''
+'''6-week cycle for 2 cycles'''
 ===References===
@@ Line 190: / Line 183: @@
 # Regine WF, Winter KA, Abrams RA, Safran H, Hoffman JP, Konski A, Benson AB, Macdonald JS, Kudrimoti MR, Fromm ML, Haddock MG, Schaefer P, Willett CG, Rich TA. Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. JAMA. 2008 Mar 5;299(9):1019-26. [http://jama.ama-assn.org/content/299/9/1019.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18319412 PubMed]
-==Gemcitabine -> Fluorouracil & RT -> Gemcitabine {{#subobject:aea7b3|Regimen=1}}==
+==Gemcitabine -> Fluorouracil & RT -> Gemcitabine {{#subobject:f8c8d9|Regimen=1}}==
 {| class="wikitable" style="float:right; margin-left: 5px;"
 |-
@@ Line 198: / Line 191: @@
 RT: '''<u>R</u>'''adiation '''<u>T</u>'''herapy
-===Regimen {{#subobject:ccacac|Variant=1}}===
+===Regimen {{#subobject:3fef3f|Variant=1}}===
 {| border="1" style="text-align:center;" !align="left"
 |'''Study'''
@@ Line 214: / Line 207: @@
 |-
 |}
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
-Prior to chemoradiation:
+'''21-day course, followed in 1 to 2 weeks by:'''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
-'''21-day course'''
-Chemoradiation:
+====Chemoradiotherapy====
-*[[Fluorouracil (5-FU)]] 250 mg/m2/day IV continuous infusion throughout radiation therapy
+*[[Fluorouracil (5-FU)]] 250 mg/m<sup>2</sup>/day IV continuous infusion throughout radiation therapy
-*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy.  The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
+*Concurrent radiation therapy, 1.8 Gy fractions x 28 fractions given 5 days per week, for a total dose of 50.4 Gy. The last 5.4 Gy of the 50.4 Gy is limited to the tumor bed.
-'''6-week course, to start 1 to 2 weeks after chemotherapy'''
+'''6-week course, followed in 3 to 5 weeks by:'''
-After chemoradiation:
+====Chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
-'''28-day cycle x 3 cycles, to start 3 to 5 weeks after completion of chemoradiation'''
+'''28-day cycle for 3 cycles'''
 ===References===
@@ Line 236: / Line 228: @@
 =Neoadjuvant chemoradiation=
-==Gemcitabine (Gemzar),  RT {{#subobject:aea7b3|Regimen=1}}==
+==Cetuximab, Gemcitabine, RT {{#subobject:aea7b3|Regimen=1}}==
 {| class="wikitable" style="float:right; margin-left: 5px;"
 |-
 |[[#toc|back to top]]
 |}
-===Regimen 1 {{#subobject:ccacac|Variant=1}}===
+===Regimen {{#subobject:c38534|Variant=1}}===
+{| border="1" style="text-align:center;" !align="left"
-Level of Evidence:
+|'''Study'''
-<span
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://annonc.oxfordjournals.org/content/23/11/2820.long Pipas et al. 2012]
+|<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 250: / Line 245: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
+|}
+====Chemoradiotherapy====
+*[[Cetuximab (Erbitux)]] as follows:
+**6 to 8 days prior radiation: 400 mg/m<sup>2</sup> IV over 120 minutes once
+**During radiation: 250 mg/m<sup>2</sup> over 60 minutes once per week for 6 doses
+*[[Gemcitabine (Gemzar)]] 50 mg/m<sup>2</sup> IV over 30 minutes twice per week for 12 doses
+**Given Monday/Thursday or Tuesday/Friday. Infusion completed ½ to 2 hours prior to RT.
+*Concurrent radiation therapy, delivered using IMRT. Gross tumor volume (GTV) was all known disease including imaging proven nodal disease. The primary planning target volume (PTV1) included the GTV with 2- to 3-cm margins in all directions as well as potential nodal involvement. Secondary planning target volume (PTV2) included the GTV with 1- to 1.5-cm margins on all sides including proven nodal involvement. Tertiary planning treatment volume (PTV3) included the area of the GTV adjacent to the vascular structures specifically the mesenteric and portal vessels with a 0.5-cm margin. The prescription dose delivered to PTV3 was 54 Gy in 28 fractions. Synchronously, PTV1 and PTV2 received 45 and 50.4 Gy, respectively. All fields were treated daily at five fractions per week.
+====Supportive medications====
+*GI prophylaxis with a proton pump inhibitor during chemoradiotherapy
+'''6-week course'''
-Chemoradiation:
+''One month following therapy, patients were restaged with CT scan of chest/abdomen/pelvis. Patients deemed to be candidates for surgical resection were offered laparotomy ∼6to 10 weeks after completion of neoadjuvant therapy.''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV  day 1, 8, 15 every 4 weeks for 3 cycles
-**Gemcitabine continued after radiation complete until 3 cycles complete
-*Concurrent radiation therapy, 2 Gy per fraction, 5 days per week, 25 fractions, total dose of 50 Gy  over 5 weeks.
-'''Restaging 8 weeks after radiation complete (2 weeks after chemotherapy complete).  Resection immediately thereafter'''
 ===References===
-# Takahashi H, Ohigashi H, Gotoh K, Marubashi S, Yamada T, Murata M, Ioka T, Uehara H, Yano M, Ishikawa O. Preoperative gemcitabine-based chemoradiation therapy for resectable and borderline resectable pancreatic cancer. Ann Surg. 2013 Dec;258(6):1040-50.[http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2013&issue=12000&article=00029&type=abstract link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/23799421 PubMed]
+# Pipas JM, Zaki BI, McGowan MM, Tsapakos MJ, Ripple GH, Suriawinata AA, Tsongalis GJ, Colacchio TA, Gordon SR, Sutton JE, Srivastava A, Smith KD, Gardner TB, Korc M, Davis TH, Preis M, Tarczewski SM, Mackenzie TA, Barth RJ Jr. Neoadjuvant cetuximab, twice-weekly gemcitabine, and intensity-modulated radiotherapy (IMRT) in patients with pancreatic adenocarcinoma. Ann Oncol. 2012 Nov;23(11):2820-7. Epub 2012 May 9. [http://annonc.oxfordjournals.org/content/23/11/2820.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22571859 PubMed]
-===Regimen 2 {{#subobject:ccacac|Variant=1}}===
+==Docetaxel, Gemcitabine, RT {{#subobject:49a407|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
-Level of Evidence:
+|-
-<span
+|[[#toc|back to top]]
+|}
+===Regimen {{#subobject:78b0ba|Variant=1}}===
+{| border="1" style="text-align:center;" !align="left"
+|'''Study'''
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://link.springer.com/article/10.1245%2FASO.2005.04.503 Pipas et al. 2005]
+|<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 269: / Line 282: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
+|}
+====Chemotherapy====
+*[[Docetaxel (Taxotere)]] 65 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 15, 29
+*[[Gemcitabine (Gemzar)]] 4000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 15, 29
+'''6-week course, followed immediately (day 43) by:'''
+====Chemoradiation====
+*[[Gemcitabine (Gemzar)]] 50 mg/m<sup>2</sup> IV over 30 minutes twice per week for 12 doses
+**Given Monday/Thursday or Tuesday/Friday. Infusion completed ½ to 2 hours prior to RT.
+*Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, for a total dose of 45 Gy to primary target volume. Then 5.4 Gy boost to secondary target volume of 1- to 1.5-cm margin on all sides, including proven nodal involvement. Total 50.4 Gy in 28 fractions.
-Neoadjuvant Chemoradiation:
+====Supportive medications====
-*[[Gemcitabine (Gemzar)]] 500 mg/m2 IV  weekly over 50 minutes for 6 weeks
+*GI prophylaxis with a proton pump inhibitor during chemoradiotherapy
-*Concurrent radiation therapy, 180 cGy x 22 with 3 cm margin to GTV then 180 cGy x 6 with 2 cm margin to GTV, total 50.4 Gy over 6 weeks
-'''Restaging after radiation complete.  4-6 week break.  Then surgery.  4-8 week break.  Then adjuvant chemotherapy'''
-Adjuvant Chemotherapy
+'''6-week course'''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 100 minutes.  On day 1 and 8 of 21 day cycles.  Repeat for 5 cycles
 ===References===
-#Landry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced,  potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010 Jun 1;101(7):587-92. [http://onlinelibrary.wiley.com/doi/10.1002/jso.21527/epdf link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20461765 PubMed]
+# Pipas JM, Barth RJ Jr, Zaki B, Tsapakos MJ, Suriawinata AA, Bettmann MA, Cates JM, Ripple GH, Sutton JE, Gordon SR, McDonnell CE, Perez RP, Redfield N, Meyer LP, Marshall JF, Cole BF, Colacchio TA. Docetaxel/Gemcitabine followed by gemcitabine and external beam radiotherapy in patients with pancreatic adenocarcinoma. Ann Surg Oncol. 2005 Dec;12(12):995-1004. Epub 2005 Nov 1. [http://link.springer.com/article/10.1245%2FASO.2005.04.503 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16252135 PubMed]
-==Gemcitabine (Gemzar), Docetaxel (Taxotere),  RT {{#subobject:aea7b3|Regimen=1}}==
+==Gemcitabine & RT {{#subobject:55e32d|Regimen=1}}==
 {| class="wikitable" style="float:right; margin-left: 5px;"
 |-
 |[[#toc|back to top]]
 |}
-===Regimen {{#subobject:ccacac|Variant=1}}===
+===Regimen 1 {{#subobject:6ce551|Variant=1}}===
+{| border="1" style="text-align:center;" !align="left"
-Level of Evidence:
+|'''Study'''
-<span
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2013&issue=12000&article=00029&type=abstract Takahashi et al. 2013]
+|<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 295: / Line 321: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
+|}
-Prior to chemoradiation:
+====Chemoradiotherapy====
-*[[Docetaxel (Taxotere)]] 65 mg/m2 IV over 60 minutes on days 1, 15, 29
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
-*[[Gemcitabine (Gemzar)]] 4000 mg/m2 IV over 30 minutes on days 1, 15, 29
+*Concurrent radiation therapy, 2 Gy per fraction, 5 days per week, 25 fractions, total dose of 50 Gy over 5 weeks.
-Chemoradiation (begins on day 43):
+'''4-week cycle for 3 cycles'''
-*[[Gemcitabine (Gemzar)]] 50 mg/m2 IV over 30 minutes twice weekly for 12 doses
-*Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions given 5 days per week, for a total dose of 45 Gy to primary target volume.  Then 5.4 Gy boost to secondary target volume of 1- to 1.5-cm margin on all sides, including proven nodal involvement.  Total 50.4 Gy in 28 fractions.
-'''6-week course, to start 1 to 2 weeks after chemotherapy.  Gemcitabine given Monday/Thursday or Tuesday/Friday.  Infusion completed ½ to 2 hours prior to RT.  GI prophylaxis with a proton pump inhibitor during chemo/RT'''
+''Restaging is performed 8 weeks after radiation complete (2 weeks after chemotherapy complete). Resection immediately thereafter, if feasible.''
-===References===
+===Regimen 2 {{#subobject:dc32dc|Variant=1}}===
-# Pipas JM, Barth RJ Jr, Zaki B, Tsapakos MJ, Suriawinata AA, Bettmann MA, Cates JM, Ripple GH, Sutton JE, Gordon SR, McDonnell CE, Perez RP, Redfield N, Meyer LP, Marshall JF, Cole BF, Colacchio TA. (2005). Docetaxel/Gemcitabine followed by gemcitabine and external beam radiotherapy in patients with pancreatic adenocarcinoma. Annals of Surgical Oncology, 12(12), 995–1004. [http://link.springer.com/article/10.1245%2FASO.2005.04.503 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/16252135 PubMed]
+{| border="1" style="text-align:center;" !align="left"
+|'''Study'''
-==Gemcitabine (Gemzar), Cetuximab (Erbitux),  RT {{#subobject:aea7b3|Regimen=1}}==
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
-{| class="wikitable" style="float:right; margin-left: 5px;"
 |-
-|[[#toc|back to top]]
+|[http://onlinelibrary.wiley.com/doi/10.1002/jso.21527/epdf Landry et al. 2010]
-|}
+|<span
-===Regimen {{#subobject:ccacac|Variant=1}}===
-Level of Evidence:
-<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 323: / Line 344: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
+|}
+====Chemoradiotherapy====
+*[[Gemcitabine (Gemzar)]] 500 mg/m<sup>2</sup> IV over 50 minutes once per week for 6 weeks
+*Concurrent radiation therapy, 180 cGy x 22 with 3 cm margin to GTV then 180 cGy x 6 with 2 cm margin to GTV, total 50.4 Gy over 6 weeks
-Prior to chemoradiation:
+''Restaging after radiation complete. 4 to 6 week break, followed by surgery, followed by 4 to 8 week break. Then adjuvant chemotherapy:''
-*[[Cetuximab (Erbitux)]] 400mg/m2 IV over 120 minutes once (loading dose)
-Chemoradiation (begins 6-8 days later):
+====Adjuvant chemotherapy====
-*[[Gemcitabine (Gemzar)]] 50 mg/m2 IV over 30 minutes twice weekly for 12 doses
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 100 minutes once per day on days 1 & 8
-*[[Cetuximab (Erbitux)]] 250 mg/m2 over 60 minutes once weekly for 6 doses
-*Concurrent radiation therapy, delivered using IMRT.  Gross tumor volume (GTV) was all known disease including imaging proven nodal disease. The primary planning target volume (PTV1) included the GTV with 2- to 3-cm margins in all directions as well as potential nodal involvement. Secondary planning target volume (PTV2) included the GTV with 1- to 1.5-cm margins on all sides including proven nodal involvement. Tertiary planning treatment volume (PTV3) included the area of the GTV adjacent to the vascular structures specifically the mesenteric and portal vessels with a 0.5-cm margin. The prescription dose delivered to PTV3 was 54 Gy in 28 fractions. Synchronously, PTV1 and PTV2 received 45 and 50.4 Gy, respectively. All fields were treated daily at five fractions per week.
-'''6-week course of concurrent chemo/RT.  Gemcitabine given Monday/Thursday or Tuesday/Friday.  Infusion completed ½ to 2 hours prior to RT.  GI prophylaxis with a proton pump inhibitor during chemo/RT.  One month following therapy, patients were restaged with CT scan of chest/abdomen/pelvis.  Patients deemed to be candidates for surgical resection were offered laparotomy ∼6to 10 weeks after completion of neoadjuvant therapy'''
+'''21-day cycle for 5 cycles'''
 ===References===
-#Pipas JM, Zaki BI, McGowan MM, Tsapakos MJ, Ripple GH, Suriawinata AA, Tsongalis GJ, Colacchio TA, Gordon SR, Sutton JE, Srivastava A, Smith KD, Gardner TB, Korc M, Davis TH, Preis M, Tarczewski SM, Mackenzie TA, Barth RJ Jr. (2012). Neoadjuvant cetuximab, twice-weekly gemcitabine, and intensity-modulated radiotherapy (IMRT) in patients with pancreatic adenocarcinoma. Annals of Oncology : Official Journal of the European Society for Medical Oncology / ESMO, 23(11), 2820–7. [http://annonc.oxfordjournals.org/content/23/11/2820.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22571859 PubMed]
+# Landry J, Catalano PJ, Staley C, Harris W, Hoffman J, Talamonti M, Xu N, Cooper H, Benson AB 3rd. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010 Jun 1;101(7):587-92. [http://onlinelibrary.wiley.com/doi/10.1002/jso.21527/epdf link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/20461765 PubMed]
+# Takahashi H, Ohigashi H, Gotoh K, Marubashi S, Yamada T, Murata M, Ioka T, Uehara H, Yano M, Ishikawa O. Preoperative gemcitabine-based chemoradiation therapy for resectable and borderline resectable pancreatic cancer. Ann Surg. 2013 Dec;258(6):1040-50.[http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2013&issue=12000&article=00029&type=abstract link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/23799421 PubMed]
-==mFOLFIRINOX, Gemcitabine, RT {{#subobject:aea7b3|Regimen=1}}==
+==mFOLFIRINOX, Gemcitabine, RT {{#subobject:b71003|Regimen=1}}==
 {| class="wikitable" style="float:right; margin-left: 5px;"
 |-
 |[[#toc|back to top]]
 |}
-===Regimen 1 {{#subobject:ccacac|Variant=1}}===
+===Regimen #1 {{#subobject:d87ec0|Variant=1}}===
+{| border="1" style="text-align:center;" !align="left"
-Level of Evidence:
+|'''Study'''
-<span
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://link.springer.com/article/10.1245%2Fs10434-014-4225-1 Blazer et al. 2015]
+|<span
 style="background:#ff0000;
 padding:3px 6px 3px 6px;
@@ Line 351: / Line 378: @@
 border-width:2px;
 border-style:solid;">Retrospective</span>
+|-
+|}
+====Modified FOLFIRINOX portion====
+*[[Irinotecan (Camptosar)]] 165 mg/m<sup>2</sup> IV over 90 minutes once on day 1
+*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 to 4 hours once on day 1
+*[[Fluorouracil (5-FU)]] 2400 mg/m<sup>2</sup> IV continuous infusion for 46 h on days 1 to 3
+====Supportive medications====
+*[[Pegfilgrastim (Neulasta)]] 6 mg SC once on day 4
+'''2-week cycle for 4 to 8 cycles'''
-Chemotherapy (Modified FOLFIRINOX):
+''Followed by complete restaging. If tumor localized but still not resectable, chemoradiotherapy was administered:''
-*[[Irinotecan (Camptosar)]] 165 mg/m2 IVPB for 90 min on day 1
-*[[Oxaliplatin (Eloxatin)]] 85 mg/m2 IVPB for 2–4 h on day 1
-*[[Fluorouracil (5-FU)]] 2,400 mg/m2 continuous infusion for 46 h on day 1-3
-*[[Pegfilgrastim (Neulasta)]] 6mg SubQ on day 4
-'''Given every 2 weeks for 4-8 cycles.  Restaging completed.  If tumor localized but still not resectable, chemoradiotherapy was administered'''
-Chemoradiotherapy (if needed):
+====Chemoradiotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2/week concurrent with radiation
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup>/week concurrent with radiation
 *Radiation was 36 Gy in 15 daily fractions
-===References===
+===Regimen #2 {{#subobject:7bb0e7|Variant=1}}===
-# Blazer M, Wu C, Goldberg RM, Phillips G, Schmidt C, Muscarella P, Wuthrick E, Williams TM, Reardon J, Christopher Ellison E, Bloomston M, Bekaii-Saab T.  Neoadjuvant Modified (m) FOLFIRINOX for Locally Advanced Unresectable (LAPC) and Borderline Resectable (BRPC) Adenocarcinoma of the Pancreas. Ann Surg Oncol. 2015 Apr;22(4):1153-9. [http://link.springer.com/article/10.1245%2Fs10434-014-4225-1 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/25358667 PubMed]
+{| border="1" style="text-align:center;" !align="left"
+|'''Study'''
-===Regimen 2  {{#subobject:ccacac|Variant=1}}===
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
-Level of Evidence:
+|-
-<span
+|[http://www.biomedcentral.com/1471-2407/12/199 Hosein et al. 2012]
+|<span
 style="background:#ff0000;
 padding:3px 6px 3px 6px;
@@ Line 374: / Line 408: @@
 border-width:2px;
 border-style:solid;">Retrospective</span>
+|-
+|}
+====FOLFIRINOX portion====
+*[[Irinotecan (Camptosar)]] 180 mg/m<sup>2</sup> IV once on day 1
+*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV once on day 1
+*[[Folinic acid (Leucovorin)]] 400mg/m<sup>2</sup> IV once on day 1
+*[[Fluorouracil (5-FU)]] 400mg/m<sup>2</sup> IV bolus on day 1
+*[[Fluorouracil (5-FU)]] 2400 mg/m<sup>2</sup> IV continuous infusion for 46 hours on days 1 to 3
-Chemotherapy (FOLFIRINOX):
+'''Cycles repeated every 2 weeks. Protocol followed "per ACCORD-11 trial"'''
-*[[Irinotecan (Camptosar)]] 180 mg/m2 IV on day 1
-*[[Oxaliplatin (Eloxatin)]] 85 mg/m2 IV on day 1
-*[[Folinic acid (Leucovorin)]] 400mg/m2 IV on day 1
-*[[Fluorouracil (5-FU)]] 400mg/m2 IV bolus on day 1
-*[[Fluorouracil (5-FU)]] 2,400 mg/m2 continuous infusion for 46 h on day 1-3
-**Cycles repeated every 2 weeks.  Protocol followed "per ACCORD-11 trial".
-'''Treatment stopped at maximum response or tolerability.  Resectable patients by imaging criteria were offered surgery, followed by postoperative chemoradiotherapy.  Unresectable patients were offered chemoradiotherapy, followed by surgery (if they became resectable) '''
+''Treatment stopped at maximum response or tolerability. Resectable patients by imaging criteria were offered surgery, followed by postoperative chemoradiotherapy. Unresectable patients were offered chemoradiotherapy, followed by surgery (if they became resectable):''
-Chemoradiotherapy:
+====Chemoradiotherapy====
-*[[Gemcitabine (Gemzar)]] 600mg/m2/week
+*[[Gemcitabine (Gemzar)]] 600 mg/m<sup>2</sup>/week
 *Radiation at 50.4 Gy in 28 fractions.
 ===References===
-#Hosein PJ, Macintyre J, Kawamura C, Maldonado JC, Ernani V, Loaiza-Bonilla A, Narayanan G, Ribeiro A, Portelance L, Merchan JR, Levi JU, Rocha-Lima CM. A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma. BMC Cancer. 2012 May 29;12:199. [http://www.biomedcentral.com/1471-2407/12/199  link to original article] '''contains verified protocol'''  [http://www.ncbi.nlm.nih.gov/pubmed/22642850 PubMed]
+# '''Retrospective:''' Hosein PJ, Macintyre J, Kawamura C, Maldonado JC, Ernani V, Loaiza-Bonilla A, Narayanan G, Ribeiro A, Portelance L, Merchan JR, Levi JU, Rocha-Lima CM. A retrospective study of neoadjuvant FOLFIRINOX in unresectable or borderline-resectable locally advanced pancreatic adenocarcinoma. BMC Cancer. 2012 May 29;12:199. [http://www.biomedcentral.com/1471-2407/12/199 link to original article] [http://www.ncbi.nlm.nih.gov/pubmed/22642850 PubMed]
+# '''Retrospective:''' Blazer M, Wu C, Goldberg RM, Phillips G, Schmidt C, Muscarella P, Wuthrick E, Williams TM, Reardon J, Christopher Ellison E, Bloomston M, Bekaii-Saab T. Neoadjuvant Modified (m) FOLFIRINOX for Locally Advanced Unresectable (LAPC) and Borderline Resectable (BRPC) Adenocarcinoma of the Pancreas. Ann Surg Oncol. 2015 Apr;22(4):1153-9. [http://link.springer.com/article/10.1245%2Fs10434-014-4225-1 link to original article]  [http://www.ncbi.nlm.nih.gov/pubmed/25358667 PubMed]
 =Locally advanced disease (unresectable)=
-==Gemcitabine (Gemzar),  RT {{#subobject:aea7b3|Regimen=1}}==
+==Gemcitabine & RT {{#subobject:a6e6fc|Regimen=1}}==
 {| class="wikitable" style="float:right; margin-left: 5px;"
 |-
 |[[#toc|back to top]]
 |}
-===Regimen #1 (600 mg/m2) {{#subobject:ccacac|Variant=1}}===
+===Regimen #1 (600 mg/m<sup>2</sup>) {{#subobject:a6de29|Variant=1}}===
 {| border="1" style="text-align:center;" !align="left"
 |'''Study'''
@@ Line 413: / Line 450: @@
 border-style:solid;">Phase II</span>
 |
-|-
-!colspan="4" align="center"|
 |-
 |[http://jco.ascopubs.org/content/29/31/4105.long Loehrer et al. 2011]
@@ Line 426: / Line 461: @@
 |-
 |}
+====Chemoradiotherapy====
+*[[Gemcitabine (Gemzar)]] 600 mg/m<sup>2</sup> IV over 30 to 60 minutes once per week during radiation
+*Concurrent radiation therapy, 1.8 Gy per fraction, 5 days per week, 28 fractions, total dose of 50.4 Gy over 5.5 weeks.
-Chemoradiation:
+'''One course, followed in 4 weeks by:'''
-*[[Gemcitabine (Gemzar)]] 600 mg/m2 IV over 30 to 60 minutes once per week during radiation
-*Concurrent radiation therapy, 1.8 Gy per fraction, 5 days per week, 28 fractions, total dose of 50.4 Gy over 5.5 weeks.
-Maintenance Chemotherapy (start 4 weeks after chemoradiation complete):
+====Maintenance chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per week, 3 out of 4 weeks
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per week, 3 out of 4 weeks
-'''28-day cycle x 5 cycles or until disease progression'''
+'''28-day cycle for 5 cycles or until disease progression'''
-===Regimen #2 (400 mg/m2) {{#subobject:c1ac3c|Variant=1}}===
+===Regimen #2 (400 mg/m<sup>2</sup>) {{#subobject:c1ac3c|Variant=1}}===
 {| border="1" style="text-align:center;" !align="left"
 |'''Study'''
@@ Line 450: / Line 486: @@
 |-
 |}
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000mg/m<sup>2</sup> IV over 30 minutes once per week for 7 weeks
+'''Radiation planning during this phase, followed by:'''
-Prior to chemoradiation:
+====Chemoradiotherapy====
-*[[Gemcitabine (Gemzar)]] 1000mg/m2 IV over 30 minutes once per week for 7 weeks
+*[[Gemcitabine (Gemzar)]] 400 mg/m<sup>2</sup> IV over 30 minutes once per week (days 1, 8, 15)
-*Radiation planning during this phase
+*Concurrent radiation therapy, 5 days per week, 28 fractions, total dose of 50.4 Gy over 5.5 weeks
-Chemoradiation:
-*[[Gemcitabine (Gemzar)]] 400 mg/m2 IV over 30 minutes once per week (days 1, 8, 15)
-*Concurrent radiation therapy, 5 days per week, 28 fractions, total dose of 50.4 Gy  over 5.5 weeks
-'''28 day cycle x 2 cycles (completion of radiation), followed by:'''
+'''28 day cycle for 2 cycles (completion of radiation), followed by:'''
-Maintenance Chemotherapy:
+====Maintenance chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000mg/m2 IV over 30 minutes once per week, 3 out of 4 weeks
+*[[Gemcitabine (Gemzar)]] 1000mg/m<sup>2</sup> IV over 30 minutes once per week, 3 out of 4 weeks
 '''28-day cycles until disease progression'''
@@ Line 495: / Line 532: @@
 |}
-''Best supportive care.  Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.''
+''Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.''
 ===References===
@@ Line 506: / Line 543: @@
 |}
 ===Regimen {{#subobject:b31bbb|Variant=1}}===
-Level of Evidence:
+{| border="1" style="text-align:center;" !align="left"
-<span
+|'''Study'''
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://jco.ascopubs.org/content/20/1/160.long Cartwright et al. 2002]
+|<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 513: / Line 554: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
+|}
+====Chemotherapy====
+*[[Capecitabine (Xeloda)]] 1250 mg/m<sup>2</sup> PO BID on days 1 to 14
-*[[Capecitabine (Xeloda)]] 1250 mg/m2 PO BID on days 1 to 14
+'''21-day cycle for up to 1 year'''
-'''21-day cycles x up to 1 year'''
 ===References===
@@ Line 540: / Line 583: @@
 |-
 |}
+====Chemotherapy====
-*[[Capecitabine (Xeloda)]] 1000 mg/m2 (rounded to the nearest 150 mg tablet) PO BID on days 1 to 14
+*[[Capecitabine (Xeloda)]] 1000 mg/m<sup>2</sup> (rounded to the nearest 150 mg tablet) PO BID on days 1 to 14
 *[[Erlotinib (Tarceva)]] 150 mg PO on days 1 to 21
@@ Line 548: / Line 591: @@
 ===References===
 # Kulke MH, Blaszkowsky LS, Ryan DP, Clark JW, Meyerhardt JA, Zhu AX, Enzinger PC, Kwak EL, Muzikansky A, Lawrence C, Fuchs CS. Capecitabine plus erlotinib in gemcitabine-refractory advanced pancreatic cancer. J Clin Oncol. 2007 Oct 20;25(30):4787-92. [http://jco.ascopubs.org/content/25/30/4787.full link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/17947726 PubMed]
+==Cisplatin & Gemcitabine {{#subobject:c30d8f|Regimen=1}}==
+{| class="wikitable" style="float:right; margin-left: 5px;"
+|-
+|[[#toc|back to top]]
+|}
+===Regimen {{#subobject:38caf7|Variant=1}}===
+{| border="1" style="text-align:center;" !align="left"
+|'''Study'''
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|'''Comparator'''
+|-
+|[http://jco.ascopubs.org/content/24/24/3946.long Heinemann et al. 2006]
+|<span
+style="background:#00CD00;
+padding:3px 6px 3px 6px;
+border-color:black;
+border-width:2px;
+border-style:solid;">Phase III</span>
+|[[Pancreatic_cancer#Gemcitabine_.28Gemzar.29_2|Gemcitabine]]
+|-
+|}
+====Chemotherapy====
+*[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV over 1 hour once per day on days 1 & 15
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 15
+'''28-day cycles'''
+===References===
+# Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. [http://jco.ascopubs.org/content/24/24/3946.long link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/16921047 PubMed]
 ==Erlotinib & Gemcitabine {{#subobject:bf797a|Regimen=1}}==
@@ Line 570: / Line 643: @@
 |-
 |}
+====Initial chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
+*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO once per day
-*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO once per day throughout
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
 '''8-week course, followed by:'''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
+====Maintenance chemotherapy====
-*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO once per day throughout
+*[[Erlotinib (Tarceva)]] 100 or 150 mg (100 mg dose recommended) PO once per day
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 '''4-week cycles'''
@@ Line 634: / Line 708: @@
 |-
 |}
+====Chemotherapy====
-*[[Fluorouracil (5-FU)]] 400 mg/m2 IV bolus, then 1200 mg/m2/day (total dose of 2400 mg/m2) IV continuous 46-hour infusion on days 1 to 2; '''given last'''
+*[[Folinic acid (Leucovorin)]] 400 mg/m<sup>2</sup> IV over 2 hours once on day 1; '''given second'''
-*[[Folinic acid (Leucovorin)]] 400 mg/m2 IV over 2 hours on day 1; '''given second'''
+*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup> IV bolus, then 1200 mg/m<sup>2</sup>/day (total dose of 2400 mg/m<sup>2</sup>) IV continuous 46-hour infusion on days 1 to 2; '''given last'''
-*[[Irinotecan (Camptosar)]] 180 mg/m2 IV over 90 minutes on day 1; '''given third together with the last 90 minutes of leucovorin; that is, irinotecan starts 30 minutes after the start of leucovorin'''
+*[[Irinotecan (Camptosar)]] 180 mg/m<sup>2</sup> IV over 90 minutes once on day 1; '''given third together with the last 90 minutes of leucovorin; that is, irinotecan starts 30 minutes after the start of leucovorin'''
-*[[Oxaliplatin (Eloxatin)]] 85 mg/m2 IV over 2 hours, '''given first'''
+*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 hours once on day 1, '''given first'''
 '''14-day cycles'''
@@ Line 664: / Line 738: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#Fluorouracil_.285-FU.29|5-FU]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jco.ascopubs.org/content/25/15/1960.long Moore et al. 2007]
@@ Line 675: / Line 747: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#Erlotinib_.26_Gemcitabine|Erlotinib & Gemcitabine]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jco.ascopubs.org/content/25/16/2212.long Herrmann et al. 2007]
@@ Line 686: / Line 756: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#GemCap.2C_GEM-CAP|GemCap]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jco.ascopubs.org/content/27/23/3778.long Poplin et al. 2009 (E6201)]
@@ Line 697: / Line 765: @@
 border-style:solid;">Phase III</span>
 |GEM FDR<br> [[Pancreatic_cancer#GemOx|GEMOX]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jco.ascopubs.org/content/27/33/5513.long Cunningham et al. 2009]
@@ Line 708: / Line 774: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#GemCap.2C_GEM-CAP|GEM-CAP]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://www.nejm.org/doi/full/10.1056/NEJMoa1011923 Conroy et al. 2011]
@@ Line 719: / Line 783: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#FOLFIRINOX|FOLFIRINOX]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://jco.ascopubs.org/content/29/31/4105.long Loehrer et al. 2011]
@@ Line 730: / Line 792: @@
 border-style:solid;">Phase III</span>
 |[[Pancreatic_cancer#Gemcitabine_.28Gemzar.29.2C_RT_2|Gemcitabine & Radiation]]
-|-
-!colspan="4" align="center"|
 |-
 |[http://www.nejm.org/doi/full/10.1056/NEJMoa1304369 Von Hoff et al. 2013 (MPACT)]
@@ Line 743: / Line 803: @@
 |-
 |}
+====Initial chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
 '''8-week course, followed by:'''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15; in Burris et al. 1997, patients with grade 2 or lower toxicities could have had doses increased to 1250 mg/m2
+====Maintenance chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15; in Burris et al. 1997, patients with grade 2 or lower toxicities could have had doses increased to 1250 mg/m<sup>2</sup>
 '''4-week cycles'''
@@ Line 768: / Line 829: @@
 |-
 |}
+====Chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 '''4-week cycles'''
@@ Line 789: / Line 850: @@
 |-
 |}
+====Chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1500 mg/m2 IV over 150 minutes (10 mg/m2/min) once per day on days 1, 8, 15
+*[[Gemcitabine (Gemzar)]] 1500 mg/m<sup>2</sup> IV over 150 minutes (10 mg/m<sup>2</sup>/min) once per day on days 1, 8, 15
 '''28-day cycles'''
@@ Line 830: / Line 891: @@
 |-
 |}
+====Initial chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, 22, 29, 36, 43
-*[[Capecitabine (Xeloda)]] 830 mg/m2 PO BID on days 1 to 21, 29 to 49
+*[[Capecitabine (Xeloda)]] 830 mg/m<sup>2</sup> PO BID on days 1 to 21, 29 to 49
 '''8-week course, THEN'''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
+====Maintenance chemotherapy====
-*[[Capecitabine (Xeloda)]] 830 mg/m2 PO BID on days 1 to 21
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
+*[[Capecitabine (Xeloda)]] 830 mg/m<sup>2</sup> PO BID on days 1 to 21
 '''4-week cycles, given until progression of disease or unacceptable toxicity'''
@@ Line 866: / Line 928: @@
 |-
 |}
+====Chemotherapy====
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 & 8
+*[[Capecitabine (Xeloda)]] 650 mg/m<sup>2</sup> PO BID on days 1 to 14
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8
+'''21-day cycle for up to 24 weeks'''
-*[[Capecitabine (Xeloda)]] 650 mg/m2 PO BID on days 1 to 14
-'''21-day cycle x up to 24 weeks'''
 ===References===
@@ Line 876: / Line 938: @@
 # Bernhard J, Dietrich D, Scheithauer W, Gerber D, Bodoky G, Ruhstaller T, Glimelius B, Bajetta E, Schüller J, Saletti P, Bauer J, Figer A, Pestalozzi BC, Köhne CH, Mingrone W, Stemmer SM, Tàmas K, Kornek GV, Koeberle D, Herrmann R; Central European Cooperative Oncology Group. Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol. 2008 Aug 1;26(22):3695-701. [http://jco.ascopubs.org/content/26/22/3695.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/18669454 PubMed]
 # Cunningham D, Chau I, Stocken DD, Valle JW, Smith D, Steward W, Harper PG, Dunn J, Tudur-Smith C, West J, Falk S, Crellin A, Adab F, Thompson J, Leonard P, Ostrowski J, Eatock M, Scheithauer W, Herrmann R, Neoptolemos JP. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009 Nov 20;27(33):5513-8. Epub 2009 Oct 26. [http://jco.ascopubs.org/content/27/33/5513.long link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/19858379 PubMed]
-==Gemcitabine & Cisplatin {{#subobject:c30d8f|Regimen=1}}==
-{| class="wikitable" style="float:right; margin-left: 5px;"
-|-
-|[[#toc|back to top]]
-|}
-===Regimen {{#subobject:38caf7|Variant=1}}===
-{| border="1" style="text-align:center;" !align="left"
-|'''Study'''
-|[[Levels_of_Evidence#Evidence|'''Evidence''']]
-|'''Comparator'''
-|-
-|[http://jco.ascopubs.org/content/24/24/3946.long Heinemann et al. 2006]
-|<span
-style="background:#00CD00;
-padding:3px 6px 3px 6px;
-border-color:black;
-border-width:2px;
-border-style:solid;">Phase III</span>
-|[[Pancreatic_cancer#Gemcitabine_.28Gemzar.29_2|Gemcitabine]]
-|-
-|}
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 30 minutes once per day on days 1 & 15
-*[[Cisplatin (Platinol)]] 50 mg/m2 IV over 1 hour once per day on days 1 & 15
-'''28-day cycles'''
-===References===
-# Heinemann V, Quietzsch D, Gieseler F, Gonnermann M, Schönekäs H, Rost A, Neuhaus H, Haag C, Clemens M, Heinrich B, Vehling-Kaiser U, Fuchs M, Fleckenstein D, Gesierich W, Uthgenannt D, Einsele H, Holstege A, Hinke A, Schalhorn A, Wilkowski R. Randomized phase III trial of gemcitabine plus cisplatin compared with gemcitabine alone in advanced pancreatic cancer. J Clin Oncol. 2006 Aug 20;24(24):3946-52. [http://jco.ascopubs.org/content/24/24/3946.long link to original article] '''contains verified regimen''' [http://www.ncbi.nlm.nih.gov/pubmed/16921047 PubMed]
 ==GemOx {{#subobject:520af|Regimen=1}}==
@@ Line 938: / Line 970: @@
 |-
 |}
+====Chemotherapy====
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV over 100 minutes once on day 1
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV over 100 minutes once on day 1
-*[[Oxaliplatin (Eloxatin)]] 100 mg/m2 IV over 2 hours once on day 2
+*[[Oxaliplatin (Eloxatin)]] 100 mg/m<sup>2</sup> IV over 2 hours once on day 2
 '''14-day cycles'''
@@ Line 969: / Line 1,001: @@
 |-
 |}
+====Chemotherapy====
 *[[Gemcitabine (Gemzar)]] as follows ('''given second'''):
-**Cycle 1: 1000 mg/m2 IV once per day on days 1, 8, 15, 29, 36, 43
+**Cycle 1: 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 29, 36, 43
-**Cycle 2 onwards: 1000 mg/m2 IV once per day on days 1, 8, 15
+**Cycle 2 onwards: 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 *[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] as follows ('''given first'''):
-**Cycle 1: 125 mg/m2 IV over 30 to 40 minutes once per day on days 1, 8, 15, 29, 36, 43
+**Cycle 1: 125 mg/m<sup>2</sup> IV over 30 to 40 minutes once per day on days 1, 8, 15, 29, 36, 43
-**Cycle 2 onwards: 125 mg/m2 IV over 30 to 40 minutes once per day on days 1, 8, 15
+**Cycle 2 onwards: 125 mg/m<sup>2</sup> IV over 30 to 40 minutes once per day on days 1, 8, 15
 '''8-week cycle followed by 28-day cycles until disease progression or intolerance'''
@@ Line 995: / Line 1,027: @@
 ''Note: The abstract and body of Von Hoff et al. 2011 contradicted each other about which drug is given first in this regimen.''
-*[[Gemcitabine (Gemzar)]] 1000 mg/m2 IV once per day on days 1, 8, 15
+====Chemotherapy====
-*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 or 125 mg/m2 IV once per day on days 1, 8, 15
+*[[Gemcitabine (Gemzar)]] 1000 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
+*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 or 125 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 '''28-day cycles'''
@@ Line 1,010: / Line 1,043: @@
 |[[#toc|back to top]]
 |}
-GTX: '''<u>G</u>'''emcitabine, '''<u>T</u>'''axotere, '''<u>X</u>'''eloda
+GTX: '''<u>G</u>'''emcitabine, '''<u>T</u>'''axotere (Docetaxel), '''<u>X</u>'''eloda (Capecitabine)
 ===Regimen {{#subobject:fc0e50|Variant=1}}===
 Level of Evidence:
@@ Line 1,020: / Line 1,053: @@
 border-style:solid;">Phase II</span>
-''Note: De Jesus-Acosta et al. 2012 lists the capecitabine dose as "750 mg/m2/day orally divided into two doses," but this is believed to be a typographical error since the original reference that it cites, Fine et al. 2008, uses capecitabine at 750 mg/m2 PO BID.  The 2009 ASCO abstract by Fine also lists this 750 mg/m2 PO BID (1500 mg/m2/day) dose.''
+''Note: De Jesus-Acosta et al. 2012 lists the capecitabine dose as "750 mg/m<sup>2</sup>/day orally divided into two doses," but this is believed to be a typographical error since the original reference that it cites, Fine et al. 2008, uses capecitabine at 750 mg/m<sup>2</sup> PO BID. The 2009 ASCO abstract by Fine also lists this 750 mg/m<sup>2</sup> PO BID (1500 mg/m<sup>2</sup>/day) dose.''
-*[[Gemcitabine (Gemzar)]] 750 mg/m2 IV over 75 minutes on days 4 & 11
+====Chemotherapy====
-*[[Docetaxel (Taxotere)]] 30 mg/m2 IV on days 4 & 11
+*[[Gemcitabine (Gemzar)]] 750 mg/m<sup>2</sup> IV over 75 minutes once per day on days 4 & 11
-*[[Capecitabine (Xeloda)]] 750 mg/m2 PO BID on days 1 to 14
+*[[Docetaxel (Taxotere)]] 30 mg/m<sup>2</sup> IV once per day on days 4 & 11
+*[[Capecitabine (Xeloda)]] 750 mg/m<sup>2</sup> PO BID on days 1 to 14
 '''21-day cycles, given until progression of disease or unacceptable toxicity'''
@@ Line 1,055: / Line 1,089: @@
 |}
-''Note: The treatment section of Pelzer et al. 2011 incorrectly lists the oxaliplatin dose as "0.85 g/m2," or 850 mg/m2.''
+''Note: The treatment section of Pelzer et al. 2011 incorrectly lists the oxaliplatin dose as "0.85 g/m<sup>2</sup>," or 850 mg/m<sup>2</sup>.''
-*[[Oxaliplatin (Eloxatin)]] 85 mg/m2 IV over 2 to 4 hours once per day on days 8 & 22
+====Chemotherapy====
-*[[Fluorouracil (5-FU)]] 2000 mg/m2 IV continuous 24-hour infusion on days 1, 8, 15, 22
+*[[Oxaliplatin (Eloxatin)]] 85 mg/m<sup>2</sup> IV over 2 to 4 hours once per day on days 8 & 22
-*[[Folinic acid (Leucovorin)]] 200 mg/m2 IV over 30 minutes once per day on days 1, 8, 15, 22
+*[[Fluorouracil (5-FU)]] 2000 mg/m<sup>2</sup> IV continuous 24-hour infusion on days 1, 8, 15, 22
+*[[Folinic acid (Leucovorin)]] 200 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15, 22
 '''42-day cycles'''
@@ Line 1,072: / Line 1,107: @@
 |}
 ===Regimen {{#subobject:8d38d2|Variant=1}}===
-Level of Evidence:
+{| border="1" style="text-align:center;" !align="left"
-<span
+|'''Study'''
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=9000&issue=00000&article=99592&type=abstract Hosein et al. 2013]
+|<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 1,079: / Line 1,118: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
-*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m2 IV over 30 minutes on days 1, 8, 15
+|}
+====Chemotherapy====
+*[[Paclitaxel, nanoparticle albumin-bound (Abraxane)]] 100 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1, 8, 15
 '''28-day cycles'''
 ===References===
-# Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer. Am J Clin Oncol. 2012 Feb 2. [Epub ahead of print] [http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=9000&issue=00000&article=99592&type=abstract link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22307213 PubMed]
+# Hosein PJ, de Lima Lopes G Jr, Pastorini VH, Gomez C, Macintyre J, Zayas G, Reis I, Montero AJ, Merchan JR, Rocha Lima CM. A Phase II Trial of nab-Paclitaxel as Second-line Therapy in Patients With Advanced Pancreatic Cancer. Am J Clin Oncol. 2013 Apr;36(2):151-6. Epub 2012 Feb 2. [http://journals.lww.com/amjclinicaloncology/pages/articleviewer.aspx?year=9000&issue=00000&article=99592&type=abstract link to original article] '''contains protocol''' [http://www.ncbi.nlm.nih.gov/pubmed/22307213 PubMed]
-==XELOX, CapeOx {{#subobject:d09d5a|Regimen=1}}==
+==XELOX; CapeOx {{#subobject:d09d5a|Regimen=1}}==
 {| class="wikitable" style="float:right; margin-left: 5px;"
 |-
 |[[#toc|back to top]]
 |}
-XELOX: '''<u>XEL</u>'''oda, '''<u>OX</u>'''aliplatin
+XELOX: '''<u>XEL</u>'''oda (Capecitabine), '''<u>OX</u>'''aliplatin
 <br>CapeOX: '''<u>Cape</u>'''citabine, '''<u>OX</u>'''aliplatin
 ===Regimen {{#subobject:57ad5f|Variant=1}}===
-Level of Evidence:
+{| border="1" style="text-align:center;" !align="left"
-<span
+|'''Study'''
+|[[Levels_of_Evidence#Evidence|'''Evidence''']]
+|-
+|[http://onlinelibrary.wiley.com/doi/10.1002/cncr.23810/full Xiong et al. 2008]
+|<span
 style="background:#EEEE00;
 padding:3px 6px 3px 6px;
@@ Line 1,103: / Line 1,148: @@
 border-width:2px;
 border-style:solid;">Phase II</span>
+|-
-If age <65 years old and [[Performance status|ECOG performance status]] <2:
+|}
-*[[Capecitabine (Xeloda)]] 1000 mg/m2 PO BID on days 1 to 14
+====Chemotherapy====
-*[[Oxaliplatin (Eloxatin)]] 130 mg/m2 IV over 2 hours on day 1
+*[[Capecitabine (Xeloda)]] as follows:
+**Age <65 years old and [[Performance status|ECOG performance status]] <2: 1000 mg/m<sup>2</sup> PO BID on days 1 to 14
-If age >65 years old and/or [[Performance status|ECOG performance status]] =2:
+**Age >65 years old and/or [[Performance status|ECOG performance status]] >=2: 750 mg/m<sup>2</sup> PO BID on days 1 to 14
-*[[Capecitabine (Xeloda)]] 750 mg/m2 PO BID on days 1 to 14
+*[[Oxaliplatin (Eloxatin)]] as follows:
-*[[Oxaliplatin (Eloxatin)]] 110 mg/m2 IV over 2 hours on day 1
+**Age <65 years old and [[Performance status|ECOG performance status]] <2: 130 mg/m<sup>2</sup> IV over 2 hours once on day 1
+**Age >65 years old and/or [[Performance status|ECOG performance status]] >=2: 110 mg/m<sup>2</sup> IV over 2 hours once on day 1
 '''21-day cycles'''

Difference between revisions of "Pancreatic cancer"

Revision as of 21:52, 17 August 2016

Adjuvant chemotherapy

Fluorouracil & Leucovorin

Regimen

Chemotherapy

References

Gemcitabine (Gemzar)

Regimen

Chemotherapy

References

Placebo (Observation)

Regimen

References

Adjuvant chemoradiation

Fluorouracil (5-FU) & RT

Regimen

Chemotherapy

Chemoradiotherapy

Chemotherapy

References

Gemcitabine -> Fluorouracil & RT -> Gemcitabine

Regimen

Chemotherapy

Chemoradiotherapy

Chemotherapy

References

Neoadjuvant chemoradiation

Cetuximab, Gemcitabine, RT

Regimen

Chemoradiotherapy

Supportive medications

References

Docetaxel, Gemcitabine, RT

Regimen

Chemotherapy

Chemoradiation

Supportive medications

References

Gemcitabine & RT

Regimen 1

Chemoradiotherapy

Regimen 2

Chemoradiotherapy

Adjuvant chemotherapy

References

mFOLFIRINOX, Gemcitabine, RT

Regimen #1

Modified FOLFIRINOX portion

Supportive medications

Chemoradiotherapy

Regimen #2

FOLFIRINOX portion

Chemoradiotherapy

References

Locally advanced disease (unresectable)

Gemcitabine & RT

Regimen #1 (600 mg/m2)

Chemoradiotherapy

Maintenance chemotherapy

Regimen #2 (400 mg/m2)

Chemotherapy

Chemoradiotherapy

Maintenance chemotherapy

References

Metastatic disease

Best supportive care

Regimen

References

Capecitabine (Xeloda)

Regimen

Chemotherapy

References

Capecitabine & Erlotinib

Regimen

Chemotherapy

References

Cisplatin & Gemcitabine

Regimen

Chemotherapy

Regimen #1 (600 mg/m²)

Regimen #2 (400 mg/m²)