Rectal cancer
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Note: the page has regimens specific to rectal cancer. Please see the colon cancer page for regimens specific to colon cancer as well as regimens intended more generically for colorectal cancer.
22 regimens on this page
48 variants on this page
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Guidelines
ESMO
- 2013: Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
NCCN
Neoadjuvant chemoradiotherapy
Capecitabine & RT
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RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hofheinz et al. 2012 | Phase III | 5-FU & RT | Non-inferior OS |
Chemoradiotherapy
- Capecitabine (Xeloda) 825 mg/m2 PO BID (1650 mg/m2/day) on days 1 to 38
- Concurrent radiation therapy, 50.4 Gy total
One course
After surgery, patients proceeded to receive adjuvant capecitabine.
References
- Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Müller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. Epub 2012 Apr 12. link to original article contains verified protocol PubMed
- O'Connell MJ, Colangelo LH, Beart RW, Petrelli NJ, Allegra CJ, Sharif S, Pitot HC, Shields AF, Landry JC, Ryan DP, Parda DS, Mohiuddin M, Arora A, Evans LS, Bahary N, Soori GS, Eakle J, Robertson JM, Moore DF Jr, Mullane MR, Marchello BT, Ward PJ, Wozniak TF, Roh MS, Yothers G, Wolmark N. Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol. 2014 Jun 20;32(18):1927-34. Epub 2014 May 5. link to PMC article PubMed
Fluorouracil & RT
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RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Sauer et al. 2004 (CAO/ARO/AIO-94) | Phase III | Adjuvant 5-FU & RT | Superior five-year cumulative incidence of local relapse |
Hofheinz et al. 2012 | Phase III | Capecitabine & RT | Non-inferior OS |
Rödel et al. 2012 (CAO/ARO/AIO-04) | Phase III | Fluorouracil, Oxaliplatin, RT | Seems to have inferior pCR rate |
Chemoradiotherapy
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion on days 1 to 5, 29 to 33
- Concurrent radiation therapy, 50.4 Gy total
One course
After surgery, patients proceeded to receive adjuvant fluorouracil.
References
- Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. link to original article PubMed
- Update: Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, Becker H, Raab HR, Villanueva MT, Witzigmann H, Wittekind C, Beissbarth T, Rödel C. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012 Jun 1;30(16):1926-33. Epub 2012 Apr 23. link to original article PubMed
- Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Müller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. Epub 2012 Apr 12. link to original article contains verified protocol PubMed
- Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R; German Rectal Cancer Study Group. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012 Jul;13(7):679-87. Epub 2012 May 23. link to original article contains protocol PubMed
- Update: Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Ströbel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. Epub 2015 Jul 15. link to original article PubMed
- O'Connell MJ, Colangelo LH, Beart RW, Petrelli NJ, Allegra CJ, Sharif S, Pitot HC, Shields AF, Landry JC, Ryan DP, Parda DS, Mohiuddin M, Arora A, Evans LS, Bahary N, Soori GS, Eakle J, Robertson JM, Moore DF Jr, Mullane MR, Marchello BT, Ward PJ, Wozniak TF, Roh MS, Yothers G, Wolmark N. Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol. 2014 Jun 20;32(18):1927-34. Epub 2014 May 5. link to PMC article PubMed
Fluorouracil, Folinic acid, RT
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RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Deng et al. 2016 (FOWARC) | Phase III | mFOLFOX6 | Seems to have superior pCR rate |
mFOLFOX6 & RT | Inferior pCR rate |
Note: this regimen is stated to be based on the de Gramont regimen in the manuscript, although the details are different than those in de Gramont et al. 2000.
Chemoradiotherapy
- Folinic acid (Leucovorin) 400 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 400 mg/m2 IV bolus, then 2400 mg/m2/day IV continuous infusion over 48 hours starting on day 1
- Concurrent radiotherapy given during cycles 2 to 4: 1.8 to 2.0 Gy once per day Monday through Friday for a total of 23 to 28 fractions over 5 to 6 weeks and a total dose of 46.0 to 50.4 Gy
14-day cycle for 5 cycles
Treatment followed by surgery and then 7 more cycles of fluorouracil & folinic acid.
References
- Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. Epub 2016 Aug 1. link to original article contains verified protocol PubMed
Fluorouracil, Oxaliplatin, RT
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RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Rödel et al. 2012 (CAO/ARO/AIO-04) | Phase III | Fluorouracil & RT | Seems to have superior pCR rate |
Chemoradiotherapy
- Fluorouracil (5-FU) 250 mg/m2/day IV continuous infusion on days 1 to 14, 22 to 35
- Oxaliplatin (Eloxatin) 50 mg/m2 IV once per day on days 1, 8, 22, 29
- Concurrent radiation therapy, 50.4 Gy total
One course
After surgery, patients proceeded to receive adjuvant FOLFOX.
References
- Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R; German Rectal Cancer Study Group. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012 Jul;13(7):679-87. Epub 2012 May 23. link to original article contains protocol PubMed
- Update: Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Ströbel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. Epub 2015 Jul 15. link to original article PubMed
- O'Connell MJ, Colangelo LH, Beart RW, Petrelli NJ, Allegra CJ, Sharif S, Pitot HC, Shields AF, Landry JC, Ryan DP, Parda DS, Mohiuddin M, Arora A, Evans LS, Bahary N, Soori GS, Eakle J, Robertson JM, Moore DF Jr, Mullane MR, Marchello BT, Ward PJ, Wozniak TF, Roh MS, Yothers G, Wolmark N. Capecitabine and oxaliplatin in the preoperative multimodality treatment of rectal cancer: surgical end points from National Surgical Adjuvant Breast and Bowel Project trial R-04. J Clin Oncol. 2014 Jun 20;32(18):1927-34. Epub 2014 May 5. link to PMC article PubMed
mFOLFOX6 & RT
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mFOLFOX6 & RT: modified FOLinic acid, Fluorouracil, OXaliplatin and Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Deng et al. 2016 (FOWARC) | Phase III | Fluorouracil, Folinic acid, RT | Superior pCR rate |
mFOLFOX6 | Not reported |
Chemoradiotherapy
- Folinic acid (Leucovorin) 400 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 400 mg/m2 IV bolus, then 2400 mg/m2/day IV continuous infusion over 48 hours starting on day 1
- Oxaliplatin (Eloxatin) 85 mg/m2 IV once on day 1
- Concurrent radiotherapy given before or after surgery at physician discretion: 1.8 to 2.0 Gy once per day Monday through Friday for a total of 23 to 28 fractions over 5 to 6 weeks and a total dose of 46.0 to 50.4 Gy
14-day cycle for 4 to 6 cycles
Treatment followed by surgery and then 6 to 8 more cycles of mFOLFOX6.
References
- Deng Y, Chi P, Lan P, Wang L, Chen W, Cui L, Chen D, Cao J, Wei H, Peng X, Huang Z, Cai G, Zhao R, Huang Z, Xu L, Zhou H, Wei Y, Zhang H, Zheng J, Huang Y, Zhou Z, Cai Y, Kang L, Huang M, Peng J, Ren D, Wang J. Modified FOLFOX6 With or Without Radiation Versus Fluorouracil and Leucovorin With Radiation in Neoadjuvant Treatment of Locally Advanced Rectal Cancer: Initial Results of the Chinese FOWARC Multicenter, Open-Label, Randomized Three-Arm Phase III Trial. J Clin Oncol. 2016 Sep 20;34(27):3300-7. Epub 2016 Aug 1. link to original article contains verified protocol PubMed
Adjuvant chemotherapy
Capecitabine monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hofheinz et al. 2012 | Phase III | Fluorouracil | Non-inferior OS |
Preceding treatment
- Neoadjuvant capecitabine & RT and surgery
Chemotherapy
- Capecitabine (Xeloda) 1250 mg/m2 PO BID (2500 mg/m2/day) on days 1 to 14
21-day cycle for 5 cycles
References
- Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Müller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. Epub 2012 Apr 12. link to original article contains verified protocol PubMed
CapeOx
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CapeOX: Capecitabine, OXaliplatin
XELOX: XELoda (Capecitabine), OXaliplatin
Regimen
See CapeOx for adjuvant treatment of colon cancer.
References
- Schmoll HJ, Cartwright T, Tabernero J, Nowacki MP, Figer A, Maroun J, Price T, Lim R, Van Cutsem E, Park YS, McKendrick J, Topham C, Soler-Gonzalez G, de Braud F, Hill M, Sirzén F, Haller DG. Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: a planned safety analysis in 1,864 patients. J Clin Oncol. 2007 Jan 1;25(1):102-9. link to original article contains verified protocol PubMed
- Update: Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. Epub 2011 Mar 7. link to original article PubMed
- Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Gilberg F, Rittweger K, Schmoll HJ. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011 Apr 10;29(11):1465-71. Epub 2011 Mar 7. link to original article contains verified protocol PubMed
FLOX
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FLOX: Fluorouracil, Leucovorin, OXaliplatin
Regimen
See FLOX for adjuvant treatment of colon cancer.
References
- Kuebler JP, Wieand HS, O'Connell MJ, Smith RE, Colangelo LH, Yothers G, Petrelli NJ, Findlay MP, Seay TE, Atkins JN, Zapas JL, Goodwin JW, Fehrenbacher L, Ramanathan RK, Conley BA, Flynn PJ, Soori G, Colman LK, Levine EA, Lanier KS, Wolmark N. Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: results from NSABP C-07. J Clin Oncol. 2007 Jun 1;25(16):2198-204. Epub 2007 Apr 30. link to original article contains verified protocol PubMed
Fluorouracil monotherapy
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Regimen #1
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hofheinz et al. 2012 | Phase III | Capecitabine | Non-inferior OS |
Preceding treatment
- Neoadjuvant fluorouracil & RT and surgery
Chemotherapy
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 4 cycles
Regimen #2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Rödel et al. 2012 (CAO/ARO/AIO-04) | Phase III | FOLFOX | Not reported |
Preceding treatment
- Neoadjuvant fluorouracil & RT and surgery
Chemotherapy
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5, 29
4 cycles (length not specified)
References
- Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Müller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. Epub 2012 Apr 12. link to original article contains verified protocol PubMed
- Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R; German Rectal Cancer Study Group. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012 Jul;13(7):679-87. Epub 2012 May 23. link to original article contains protocol PubMed
- Update: Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Ströbel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. Epub 2015 Jul 15. link to original article PubMed
Fluorouracil & Folinic acid
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hong et al. 2014 (ADORE) | Randomized Phase II | FOLFOX | Seems to have inferior DFS |
Preceding treatment
- Fluoropyrimidine-based chemoradiation and total mesorectal excision
Chemotherapy
- Fluorouracil (5-FU) 380 mg/m2 IV once per day on days 1 to 5
- Folinic acid (Leucovorin) 20 mg/m2 IV once per day on days 1 to 5
28-day cycle for 4 cycles
References
- Hong YS, Nam BH, Kim KP, Kim JE, Park SJ, Park YS, Park JO, Kim SY, Kim TY, Kim JH, Ahn JB, Lim SB, Yu CS, Kim JC, Yun SH, Kim JH, Park JH, Park HC, Jung KH, Kim TW. Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial. Lancet Oncol. 2014 Oct;15(11):1245-53. Epub 2014 Sep 4. link to original article contains protocol PubMed
FOLFOX
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FOLFOX: FOLinic acid, Fluorouracil, OXaliplatin
Regimen #1
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hong et al. 2014 (ADORE) | Randomized Phase II | Fluorouracil & 5-FU | Seems to have superior DFS |
Preceding treatment
- Fluoropyrimidine-based chemoradiation and total mesorectal excision
Chemotherapy
- Fluorouracil (5-FU) 400 mg/m2 IV bolus on day 1, then 1200 mg/m2/day IV continuous infusion over 46 hours (total dose: 2800 mg/m2)
- Folinic acid (Leucovorin) 200 mg/m2 IV once on day 1
- Oxaliplatin (Eloxatin) 85 mg/m2 IV once on day 1
14-day cycle for 8 cycles
Regimen #2
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Rödel et al. 2012 (CAO/ARO/AIO-04) | Phase III | Fluorouracil | Not reported |
Note: it is unclear from the abstract whether the intent is for 8 cycles (16 doses of oxaliplatin) or 8 doses of oxaliplatin.
Preceding treatment
- Neoadjuvant fluorouracil, oxaliplatin, RT and surgery
Chemotherapy
- Fluorouracil (5-FU) 2400 mg/m2 IV continuous infusion over 48 hours twice per cycle on days 1 & 2, 15 & 16
- Folinic acid (Leucovorin) 400 mg/m2 IV once per day on days 1 & 15
- Oxaliplatin (Eloxatin) 100 mg/m2 IV once per day on days 1 & 15
8 cycles
References
- Hong YS, Nam BH, Kim KP, Kim JE, Park SJ, Park YS, Park JO, Kim SY, Kim TY, Kim JH, Ahn JB, Lim SB, Yu CS, Kim JC, Yun SH, Kim JH, Park JH, Park HC, Jung KH, Kim TW. Oxaliplatin, fluorouracil, and leucovorin versus fluorouracil and leucovorin as adjuvant chemotherapy for locally advanced rectal cancer after preoperative chemoradiotherapy (ADORE): an open-label, multicentre, phase 2, randomised controlled trial. Lancet Oncol. 2014 Oct;15(11):1245-53. Epub 2014 Sep 4. link to original article contains protocol PubMed
- Rödel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sülberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Köhler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R; German Rectal Cancer Study Group. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012 Jul;13(7):679-87. Epub 2012 May 23. link to original article contains protocol PubMed
- Update: Rödel C, Graeven U, Fietkau R, Hohenberger W, Hothorn T, Arnold D, Hofheinz RD, Ghadimi M, Wolff HA, Lang-Welzenbach M, Raab HR, Wittekind C, Ströbel P, Staib L, Wilhelm M, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R, Liersch T; German Rectal Cancer Study Group. Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2015 Aug;16(8):979-89. Epub 2015 Jul 15. link to original article PubMed
S-1 monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Oki et al. 2016 (ACTS-RC) | Phase III | UFT | Seems to have superior RFS |
Note: these patients did not receive preoperative therapy.
Preceding treatment
- Curative resection for stage II or stage III rectal cancer, within 49 days
Chemotherapy
- Tegafur, gimeracil, oteracil (S-1) as follows:
- BSA less than 1.25 m2: 40 mg PO BID on days 1 to 28
- BSA 1.25 to 1.50 m2: 50 mg PO BID on days 1 to 28
- BSA 1.50 or greater m2: 60 mg PO BID on days 1 to 28
42-day cycles for 12 months
References
- Oki E, Murata A, Yoshida K, Maeda K, Ikejiri K, Munemoto Y, Sasaki K, Matsuda C, Kotake M, Suenaga T, Matsuda H, Emi Y, Kakeji Y, Baba H, Hamada C, Saji S, Maehara Y. A randomized phase III trial comparing S-1 versus UFT as adjuvant chemotherapy for stage II/III rectal cancer (JFMC35-C1: ACTS-RC). Ann Oncol. 2016 Jul;27(7):1266-72. Epub 2016 Apr 7. link to original articlelink to PMC article contains verified protocol PubMed
UFT monotherapy
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Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Oki et al. 2016 (ACTS-RC) | Phase III | S-1 | Seems to have inferior RFS |
Note: these patients did not receive preoperative therapy.
Preceding treatment
- Curative resection for stage II or stage III rectal cancer, within 49 days
Chemotherapy
- Tegafur and uracil (UFT) as follows:
- BSA less than 1.25 m2: 250 mg PO BID on days 1 to 5
- BSA 1.25 or greater m2: 300 mg PO BID on days 1 to 5
7-day cycles for 12 months
References
- Oki E, Murata A, Yoshida K, Maeda K, Ikejiri K, Munemoto Y, Sasaki K, Matsuda C, Kotake M, Suenaga T, Matsuda H, Emi Y, Kakeji Y, Baba H, Hamada C, Saji S, Maehara Y. A randomized phase III trial comparing S-1 versus UFT as adjuvant chemotherapy for stage II/III rectal cancer (JFMC35-C1: ACTS-RC). Ann Oncol. 2016 Jul;27(7):1266-72. Epub 2016 Apr 7. link to original articlelink to PMC article contains verified protocol PubMed
Adjuvant chemoradiotherapy
Capecitabine, then Capecitabine & RT, then Capecitabine
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RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hofheinz et al. 2012 | Phase III | 5-FU, then 5-FU & RT, then 5-FU | Non-inferior OS |
Chemotherapy, part 1
- Capecitabine (Xeloda) 1250 mg/m2 PO BID (2500 mg/m2/day) on days 1 to 14
21-day cycle for 2 cycles, followed by:
Chemoradiotherapy
- Capecitabine (Xeloda) 825 mg/m2 PO BID (1650 mg/m2/day) on days 1 to 38
- Concurrent radiation therapy, 50.4 Gy total
Followed by:
Chemotherapy, part 2
- Capecitabine (Xeloda) 1250 mg/m2 PO BID (2500 mg/m2/day) on days 1 to 14
21-day cycle for 3 cycles
References
- Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Müller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. Epub 2012 Apr 12. link to original article contains verified protocol PubMed
Fluorouracil, then Fluorouracil & RT, then Fluorouracil
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RT: Radiation Therapy
Regimen #1, Bolus 5-FU (500 mg/m2), then 5-FU & RT, then Bolus 5-FU (450 mg/m2)
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Smalley et al. 2006 (GI INT 0144) | Phase III | Bolus 5-FU, then RT, then Bolus 5-FU | Seems not superior |
Continuous 5-FU, then 5-FU & RT, then Continuous 5-FU | Seems not superior |
Chemotherapy, part 1
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles, followed immediately by:
Chemoradiotherapy
- Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion while radiation is being given
- Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions for an initial dose of 45 Gy, which is followed by a 1.8 Gy x 3 fraction (5.4 Gy total) boost to the tumor bed and adjacent lymph nodes, and then optionally a 1.8 Gy x 2 fraction (3.6 Gy total) boost to the tumor bed and a 2 cm margin if the small bowel could be avoided
One course, followed 28 days later by:
Chemotherapy, part 2
- Fluorouracil (5-FU) 450 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles
Regimen #2, Bolus 5-FU (500 mg/m2), then 5-FU & RT, then Bolus 5-FU (500 mg/m2)
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Hofheinz et al. 2012 | Phase III | Capecitabine, then Capecitabine & RT, then Capecitabine | Non-inferior OS |
Chemotherapy, part 1
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles, followed by:
Chemoradiotherapy
- Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion while radiation is being given
- Concurrent radiation therapy, 50.4 Gy total
Followed by:
Chemotherapy, part 2
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles
Regimen #3, Continuous 5-FU, then 5-FU & RT, then Continuous 5-FU
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Smalley et al. 2006 (GI INT 0144) | Phase III | Bolus 5-FU, then 5-FU & RT, then Bolus 5-FU | Seems not superior |
Bolus 5-FU, then RT, then Bolus 5-FU | Seems not superior |
Chemotherapy, part 1
- Fluorouracil (5-FU) 300 mg/m2/day IV continuous infusion on days 1 to 42
8-week course, followed in 2 weeks by:
Chemoradiotherapy
- Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion while radiation is being given
- Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions for an initial dose of 45 Gy, which is followed by a 1.8 Gy x 3 fraction (5.4 Gy total) boost to the tumor bed and adjacent lymph nodes, and then optionally a 1.8 Gy x 2 fraction (3.6 Gy total) boost to the tumor bed and a 2 cm margin if the small bowel could be avoided
Followed in 28 days by:
Chemotherapy, part 2
- Fluorouracil (5-FU) 300 mg/m2/day IV continuous infusion on days 1 to 56
56-day course
Regimen #4
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Tepper et al. 1997 (GI INT 0114) | Phase III | 5-FU & Leucovorin, then 5-FU, Leucovorin, RT, then 5-FU & Leucovorin | Seems not superior |
Levamisole combination #1 | Seems not superior | ||
Levamisole combination #2 | Seems not superior |
Chemotherapy, part 1
- Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles, followed by:
Chemoradiotherapy
- Fluorouracil (5-FU) 500 mg/m2 IV bolus 3 days per week during weeks 1 & 5 of radiation, preferably within 2 hours after the day's radiation
- Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions for an initial dose of 45 Gy, which is followed by a 1.8 Gy x 3 fraction (5.4 Gy total) boost to the tumor bed and adjacent lymph nodes, and then optionally a 1.8 Gy x 2 fraction (3.6 Gy total) boost to the tumor bed and a 2 cm margin if the small bowel could be avoided
Followed in 28 days by:
Chemotherapy, part 2
- Fluorouracil (5-FU) 450 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles
Regimen #5
Note: The O'Connell et al. 1994 reference cited by the NCCN, Rectal Cancer version 3.2012, contains a different regimen than what is listed by the NCCN. No primary reference could be found for this exact regimen as listed by the NCCN.
- Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion either 5 or 7 days per week during radiation therapy
References
- O'Connell MJ, Martenson JA, Wieand HS, Krook JE, Macdonald JS, Haller DG, Mayer RJ, Gunderson LL, Rich TA. Improving adjuvant therapy for rectal cancer by combining protracted-infusion fluorouracil with radiation therapy after curative surgery. N Engl J Med. 1994 Aug 25;331(8):502-7. link to original article PubMed
- Tepper JE, O'Connell MJ, Petroni GR, Hollis D, Cooke E, Benson AB 3rd, Cummings B, Gunderson LL, Macdonald JS, Martenson JA. Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: initial results of intergroup 0114. J Clin Oncol. 1997 May;15(5):2030-9. link to original article contains verified protocol PubMed
- Update: Tepper JE, O'Connell M, Niedzwiecki D, Hollis DR, Benson AB 3rd, Cummings B, Gunderson LL, Macdonald JS, Martenson JA, Mayer RJ. Adjuvant therapy in rectal cancer: analysis of stage, sex, and local control--final report of intergroup 0114. J Clin Oncol. 2002 Apr 1;20(7):1744-50. link to original article contains verified protocol PubMed content property of HemOnc.org
- Smalley SR, Benedetti JK, Williamson SK, Robertson JM, Estes NC, Maher T, Fisher B, Rich TA, Martenson JA, Kugler JW, Benson AB 3rd, Haller DG, Mayer RJ, Atkins JN, Cripps C, Pedersen J, Periman PO, Tanaka MS Jr, Leichman CG, Macdonald JS. Phase III trial of fluorouracil-based chemotherapy regimens plus radiotherapy in postoperative adjuvant rectal cancer: GI INT 0144. J Clin Oncol. 2006 Aug 1;24(22):3542-7. link to original article contains verified protocol PubMed
- Hofheinz RD, Wenz F, Post S, Matzdorff A, Laechelt S, Hartmann JT, Müller L, Link H, Moehler M, Kettner E, Fritz E, Hieber U, Lindemann HW, Grunewald M, Kremers S, Constantin C, Hipp M, Hartung G, Gencer D, Kienle P, Burkholder I, Hochhaus A. Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial. Lancet Oncol. 2012 Jun;13(6):579-88. Epub 2012 Apr 13. link to original article contains verified protocol PubMed
5-FU & Leucovorin, then 5-FU, Leucovorin, RT, then 5-FU & Leucovorin
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Tepper et al. 1997 (GI INT 0114) | Phase III | 5-FU, then 5-FU & RT, then 5-FU | Seems not superior |
Levamisole combination #1 | Seems not superior | ||
Levamisole combination #2 | Seems not superior |
Chemotherapy, part 1
- Fluorouracil (5-FU) 425 mg/m2 IV bolus once per day on days 1 to 5, given after Folinic acid (Leucovorin)
- Folinic acid (Leucovorin) 20 mg/m2 IV bolus once per day on days 1 to 5, given before Fluorouracil (5-FU)
28-day cycle for 2 cycles, followed by:
Chemoradiotherapy
- Fluorouracil (5-FU) 400 mg/m2 IV bolus 4 days per week during weeks 1 & 5 of radiation, preferably within 2 hours after the day's radiation
- Folinic acid (Leucovorin) 20 mg/m2 IV bolus 4 days per week during weeks 1 & 5 of radiation, preferably within 2 hours after the day's radiation
- Concurrent radiation therapy, 1.8 Gy fractions x 25 fractions for an initial dose of 45 Gy, which is followed by a 1.8 Gy x 3 fraction (5.4 Gy total) boost to the tumor bed and adjacent lymph nodes, and then optionally a 1.8 Gy x 2 fraction (3.6 Gy total) boost to the tumor bed and a 2 cm margin if the small bowel could be avoided
Followed in 28 days by:
Chemotherapy, part 2
- Fluorouracil (5-FU) 380 mg/m2 IV bolus once per day on days 1 to 5
- Folinic acid (Leucovorin) 20 mg/m2 IV bolus once per day on days 1 to 5
28-day cycle for 2 cycles
References
- Tepper JE, O'Connell MJ, Petroni GR, Hollis D, Cooke E, Benson AB 3rd, Cummings B, Gunderson LL, Macdonald JS, Martenson JA. Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: initial results of intergroup 0114. J Clin Oncol. 1997 May;15(5):2030-9. link to original article contains verified protocol PubMed
- Update: Tepper JE, O'Connell M, Niedzwiecki D, Hollis DR, Benson AB 3rd, Cummings B, Gunderson LL, Macdonald JS, Martenson JA, Mayer RJ. Adjuvant therapy in rectal cancer: analysis of stage, sex, and local control--final report of intergroup 0114. J Clin Oncol. 2002 Apr 1;20(7):1744-50. link to original article contains verified protocol PubMed
Fluorouracil, Folinic acid, Levamisole, RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
---|---|---|---|
Tepper et al. 1997 (GI INT 0114) | Phase III | 5-FU, then 5-FU & RT, then 5-FU | Seems not superior |
5-FU & Leucovorin, then 5-FU, Leucovorin, RT, then 5-FU & Leucovorin | Seems not superior |
Two levamisole combinations were evaluated and neither were superior; here for reference purposes only.
Chemotherapy
References
- Tepper JE, O'Connell MJ, Petroni GR, Hollis D, Cooke E, Benson AB 3rd, Cummings B, Gunderson LL, Macdonald JS, Martenson JA. Adjuvant postoperative fluorouracil-modulated chemotherapy combined with pelvic radiation therapy for rectal cancer: initial results of intergroup 0114. J Clin Oncol. 1997 May;15(5):2030-9. link to original article contains verified protocol PubMed
- Update: Tepper JE, O'Connell M, Niedzwiecki D, Hollis DR, Benson AB 3rd, Cummings B, Gunderson LL, Macdonald JS, Martenson JA, Mayer RJ. Adjuvant therapy in rectal cancer: analysis of stage, sex, and local control--final report of intergroup 0114. J Clin Oncol. 2002 Apr 1;20(7):1744-50. link to original article contains verified protocol PubMed
Advanced or metastatic disease
See the colon cancer page for colorectal cancer regimens.