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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main pancreatic cancer page for regimens that include active anticancer treatment.

Neoadjuvant therapy

No neoadjuvant therapy

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Terminated for low accrual (NEOPAC)	2009-2018	Phase 3 (C)	GemOx	No results
Versteijne et al. 2020 (PREOPANC)	2013-2017	Phase 3 (C)	Gemcitabine & RT	Seems to have inferior OS¹

¹Reported efficacy is based on the 2022 update.
No treatment prior to surgery.

Subsequent treatment

Surgery

References

PREOPANC: Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. link to original article PubMed EudraCT 2012-003181-40
1. Update: Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. Epub 2022 Jan 27. link to original article PubMed
NEOPAC: NCT01314027

Adjuvant therapy

Observation

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Klinkenbijl et al. 1999 (EORTC 40891)	1987-1995	Phase 3 (C)	5-FU & RT	Did not meet primary endpoint of OS24
Neoptolemos et al. 2001 (ESPAC-1)	1994-2000	Phase 3 (C)	1. FULV	Inferior OS
Neoptolemos et al. 2001 (ESPAC-1)	1994-2000	Phase 3 (C)	2. 5-FU & RT 3. 5-FU & RT, then FULV	Seems to have superior OS
Oettle et al. 2007 (CONKO-001)	1998-2004	Phase 3 (C)	Gemcitabine	Seems to have inferior OS
Ueno et al. 2009 (JSAP-02)	2002-2005	Phase 3 (C)	Gemcitabine	Inferior DFS

No active antineoplastic treatment. Reported efficacy for ESPAC-1 is based on the 2004 update and efficacy for CONKO-001 is based on 2013 update.

Preceding treatment

Surgery

References

EORTC 40891: Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. link to original article link to PMC article PubMed
1. Update: Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. link to original article PubMed
ESPAC-1: Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. link to original article PubMed
1. Update: 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 PubMed
CONKO-001: 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 PubMed ISRCTN34802808
1. Update: Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. link to original article PubMed
JSAP-02: Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. link to original article link to original article PubMed

Metastatic disease, refractory

Best supportive care

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Gilliam et al. 2012 (PC6)	2001-2002	Phase 3 (C)	G17DT	Did not meet primary endpoint of OS
Pelzer et al. 2011 (CONKO-003)	2002-12 to 2003-12	Phase 3 (C)	OFF	Inferior OS
Ciuleanu et al. 2009 (TH-CR-302)	2004-2006	Phase 3 (C)	Glufosfamide	Did not meet primary endpoint of OS

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

References

PC6: Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, Whitehead A, Takhar A, Rowlands BJ, Beckingham IJ. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012 Apr;41(3):374-9. link to original article PubMed NCT02118077
TH-CR-302: Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. link to original article PubMed NCT00099294
CONKO-003: 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 PubMed NCT00786058

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-The purpose of this page is to provide references to "null therapy" such as placebo and observation. While not clinically relevant, these references provide further insight into the historical development of the treatment landscape. See the [[Pancreatic cancer|main pancreatic cancer page]] for current regimens.
+<span id="BackToTop"></span>
+<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
+[[#top|Back to Top]]
+</div>
+The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Pancreatic cancer|main pancreatic cancer page]] for regimens that include active anticancer treatment.
 {{TOC limit|limit=3}}
@@ Line 5: / Line 9: @@
 =Neoadjuvant therapy=
 ==No neoadjuvant therapy==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
 !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+|-
+|Terminated for low accrual (NEOPAC)
+|2009-2018
+| style="background-color:#1a9851" |Phase 3 (C)
+|[[#GemOx_999|GemOx]]
+| style="background-color:#d3d3d3" |No results
 |-
 |[https://doi.org/10.1200/jco.19.02274 Versteijne et al. 2020 (PREOPANC)]
 |2013-2017
-| style="background-color:#1a9851" |Phase III (C)
+| style="background-color:#1a9851" |Phase 3 (C)
-|Gemcitabine & RT, then Gemcitabine
+|[[#Gemcitabine_.26_RT|Gemcitabine & RT]]
-| style="background-color:#fee08b" |Might have inferior OS
+| style="background-color:#fc8d59" |Seems to have inferior OS<sup>1</sup>
 |-
 |}
+''<sup>1</sup>Reported efficacy is based on the 2022 update.''<br>
 ''No treatment prior to surgery.''
+<div class="toccolours" style="background-color:#cbd5e8">
 ====Subsequent treatment====
 *[[Surgery#Pancreatic_cancer_surgery|Surgery]]
+</div></div>
 ===References===
-#'''PREOPANC:''' Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. [https://doi.org/10.1200/jco.19.02274 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32105518 PubMed]
+#'''PREOPANC:''' Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. [https://doi.org/10.1200/jco.19.02274 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32105518/ PubMed] EudraCT 2012-003181-40
+##'''Update:''' Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. Epub 2022 Jan 27. [https://doi.org/10.1200/jco.21.02233 link to original article] [https://pubmed.ncbi.nlm.nih.gov/35084987/ PubMed]
+#'''NEOPAC:''' [https://clinicaltrials.gov/study/NCT01314027 NCT01314027]
 =Adjuvant therapy=
 ==Observation==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
@@ Line 50: / Line 56: @@
 |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420941/ Klinkenbijl et al. 1999 (EORTC 40891)]
 |1987-1995
-| style="background-color:#1a9851" |Phase III (C)
+| style="background-color:#1a9851" |Phase 3 (C)
-|5-FU & RT
+|[[#Fluorouracil_.26_RT_999|5-FU & RT]]
 | style="background-color:#ffffbf" |Did not meet primary endpoint of OS24
 |-
-| rowspan="2" |[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(01)06651-X/fulltext Neoptolemos et al. 2001 (ESPAC-1)]
+| rowspan="2" |[https://doi.org/10.1016/S0140-6736(01)06651-X Neoptolemos et al. 2001 (ESPAC-1)]
 |rowspan=2|1994-2000
-| rowspan="2" style="background-color:#1a9851" |Phase III (C)
+| rowspan="2" style="background-color:#1a9851" |Phase 3 (C)
 |1. [[Pancreatic_cancer#FULV|FULV]]
 | style="background-color:#d73027" |Inferior OS
 |-
-|2. [[Pancreatic_cancer#Fluorouracil.2FFluorouracil_.26_RT|5-FU/5-FU & RT]]<br> 3. 5-FU & RT, then FULV
+|2. [[Pancreatic_cancer#Fluorouracil_.26_RT|5-FU & RT]]<br> 3. [[#Fluorouracil_.26_RT_999|5-FU & RT]], then [[Pancreatic_cancer#FULV|FULV]]
 | style="background-color:#91cf60" |Seems to have superior OS
 |-
 |[http://jama.ama-assn.org/content/297/3/267.long Oettle et al. 2007 (CONKO-001)]
 |1998-2004
-| style="background-color:#1a9851" |Phase III (C)
+| style="background-color:#1a9851" |Phase 3 (C)
 |[[Pancreatic_cancer#Gemcitabine_monotherapy|Gemcitabine]]
 | style="background-color:#fc8d59" |Seems to have inferior OS
@@ Line 71: / Line 77: @@
 |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743365/ Ueno et al. 2009 (JSAP-02)]
 |2002-2005
-| style="background-color:#1a9851" |Phase III (C)
+| style="background-color:#1a9851" |Phase 3 (C)
 |[[Pancreatic_cancer#Gemcitabine_monotherapy|Gemcitabine]]
 | style="background-color:#d73027" |Inferior DFS
@@ Line 77: / Line 83: @@
 |}
 ''No active antineoplastic treatment. Reported efficacy for ESPAC-1 is based on the 2004 update and efficacy for CONKO-001 is based on 2013 update.''
+<div class="toccolours" style="background-color:#cbd5e8">
 ====Preceding treatment====
 *[[Surgery#Pancreatic_cancer_surgery|Surgery]]
+</div></div>
 ===References===
-#'''EORTC 40891:''' Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. [https://insights.ovid.com/pubmed?pmid=10615932 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420941/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/10615932 PubMed]
+#'''EORTC 40891:''' Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. [https://doi.org/10.1097/00000658-199912000-00006 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1420941/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/10615932/ PubMed]
-##'''Update:''' Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. [https://insights.ovid.com/pubmed?pmid=17968163 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/17968163 PubMed]
+##'''Update:''' Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. [https://doi.org/10.1097/SLA.0b013e318156eef3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17968163/ PubMed]
-#'''ESPAC-1:''' Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(01)06651-X/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/11716884 PubMed]
+#'''ESPAC-1:''' Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. [https://doi.org/10.1016/S0140-6736(01)06651-X link to original article] [https://pubmed.ncbi.nlm.nih.gov/11716884/ PubMed]
-##'''Update:''' 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. [https://www.nejm.org/doi/full/10.1056/NEJMoa032295 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/15028824 PubMed]
+##'''Update:''' 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. [https://doi.org/10.1056/NEJMoa032295 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15028824/ PubMed]
-#'''CONKO-001:''' 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. [http://jama.ama-assn.org/content/297/3/267.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/17227978 PubMed]
+#'''CONKO-001:''' 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. [http://jama.ama-assn.org/content/297/3/267.long link to original article] [https://pubmed.ncbi.nlm.nih.gov/17227978/ PubMed] ISRCTN34802808
-##'''Update:''' Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. [http://jama.jamanetwork.com/article.aspx?articleid=1750131 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/24104372 PubMed]
+##'''Update:''' Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. [http://jama.jamanetwork.com/article.aspx?articleid=1750131 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24104372/ PubMed]
-#'''JSAP-02:''' Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. [https://www.nature.com/articles/6605256 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743365/ link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/19690548 PubMed]
+#'''JSAP-02:''' Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009 Sep 15;101(6):908-15. Epub 2009 Aug 18. [https://doi.org/10.1038/sj.bjc.6605256 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743365/ link to original article] [https://pubmed.ncbi.nlm.nih.gov/19690548/ PubMed]
 =Metastatic disease, refractory=
 ==Best supportive care==
-{| class="wikitable" style="float:right; margin-left: 5px;"
+<div class="toccolours" style="background-color:#eeeeee">
-|-
-|[[#top|back to top]]
-|}
 ===Regimen===
 {| class="wikitable sortable" style="width: 100%; text-align:center;"
 !style="width: 20%"|Study
-!style="width: 20%"|Years of enrollment
+!style="width: 20%"|Dates of enrollment
 !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 !style="width: 20%"|Comparator
 !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 |-
-|[https://www.ejcancer.com/article/S0959-8049(08)01051-4/fulltext Ciuleanu et al. 2009]
+|[https://doi.org/10.1097/mpa.0b013e31822ade7e Gilliam et al. 2012 (PC6)]
-|NR in abstract
+|2001-2002
-| style="background-color:#1a9851" |Phase III (C)
+| style="background-color:#1a9851" |Phase 3 (C)
-|Glufosfamide
+|[[#G17DT_monotherapy_999|G17DT]]
 | style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 |-
-|[https://www.ejcancer.com/article/S0959-8049(11)00260-7/abstract Pelzer et al. 2011 (CONKO-003)]
+|[https://doi.org/10.1016/j.ejca.2011.04.011 Pelzer et al. 2011 (CONKO-003)]
-|NR in abstract
+|2002-12 to 2003-12
-| style="background-color:#1a9851" |Phase III (C)
+| style="background-color:#1a9851" |Phase 3 (C)
 |[[Pancreatic_cancer#OLF|OFF]]
 | style="background-color:#d73027" |Inferior OS
+|-
+|[https://doi.org/10.1016/j.ejca.2008.12.022 Ciuleanu et al. 2009 (TH-CR-302)]
+|2004-2006
+| style="background-color:#1a9851" |Phase 3 (C)
+|[[#Glufosfamide_monotherapy_999|Glufosfamide]]
+| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 |-
 |}
 ''Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.''
+</div>
 ===References===
+#'''PC6:''' Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, Whitehead A, Takhar A, Rowlands BJ, Beckingham IJ. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012 Apr;41(3):374-9. [https://doi.org/10.1097/mpa.0b013e31822ade7e link to original article] [https://pubmed.ncbi.nlm.nih.gov/22228104/ PubMed] [https://clinicaltrials.gov/study/NCT02118077 NCT02118077]
-#Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. [https://www.ejcancer.com/article/S0959-8049(08)01051-4/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/19188061 PubMed]
+#'''TH-CR-302:''' Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. [https://doi.org/10.1016/j.ejca.2008.12.022 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19188061/ PubMed] [https://clinicaltrials.gov/study/NCT00099294 NCT00099294]
-#'''CONKO-003:''' 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. [https://www.ejcancer.com/article/S0959-8049(11)00260-7/abstract link to original article] '''contains verified protocol'''--with error as noted above [https://www.ncbi.nlm.nih.gov/pubmed/21565490 PubMed]
+#'''CONKO-003:''' 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. [https://doi.org/10.1016/j.ejca.2011.04.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21565490/ PubMed] [https://clinicaltrials.gov/study/NCT00786058 NCT00786058]
 [[Category:Pancreatic cancer regimens]]

Difference between revisions of "Pancreatic cancer - null regimens"

Latest revision as of 01:22, 8 March 2024

Contents

Neoadjuvant therapy

No neoadjuvant therapy

Regimen

Subsequent treatment

References

Adjuvant therapy

Observation

Regimen

Preceding treatment

References

Metastatic disease, refractory

Best supportive care

Regimen

References

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