Rectal cancer

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Please be aware that some regimens listed here are protocols for colon cancer, not rectal cancer. We have tried to only include rectal cancer protocols when they are available.

22 regimens on this page 48 variants on this page

Neoadjuvant chemoradiation

Capecitabine & RT

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RT: Radiation Therapy

Regimen

Study	Evidence	Comparator
Hofheinz et al. 2012	Phase III	5-FU & RT

• 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

1. 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 & RT

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RT: Radiation Therapy

Regimen

Study	Evidence	Comparator
Hofheinz et al. 2012	Phase III	Capecitabine & RT

• Fluorouracil (5-FU) 1000 mg/m2 IV once per day 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

1. 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

Adjuvant chemotherapy

Capecitabine (Xeloda)

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Regimen

Study	Evidence	Comparator
Hofheinz et al. 2012	Phase III	Fluorouracil

Treatment preceded by neoadjuvant capecitabine & RT and surgery.

• Capecitabine (Xeloda) 1250 mg/m2 PO BID (2500 mg/m2/day) on days 1 to 14

21-day cycle x 5 cycles

References

1. 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 (XELOX)

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

Regimen

Study	Evidence	Comparator
Schmoll et al. 2007	Phase III	Fluorouracil & Folinic acid

• Capecitabine (Xeloda) 1000 mg/m2 PO BID, starting the evening of day 1, to continue through the morning of day 15 (28 total doses)
• Oxaliplatin (Eloxatin) 130 mg/m2 IV over 2 hours once on day 1

21-day cycle x 8 cycles

References

1. 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
   1. 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

FLOX

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FLOX: Fluorouracil, Leucovorin, OXaliplatin

Regimen

Level of Evidence: Phase III

• Fluorouracil (5-FU) 500 mg/m2 IV bolus on days 1, 8, 15, 22, 29, 36, to start 1 hour after start of leucovorin
• Folinic acid (Leucovorin) 500 mg/m2 IV over 2 hours on days 1, 8, 15, 22, 29, 36, given before Fluorouracil (5-FU)
• Oxaliplatin (Eloxatin) 85 mg/m2 IV over 2 hours on days 1, 15, 29, given prior to 5-FU and leucovorin

8-week cycles x 3 cycles

References

1. 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 (5-FU)

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Regimen

Study	Evidence	Comparator
Hofheinz et al. 2012	Phase III	Capecitabine

Treatment preceded by neoadjuvant fluorouracil & RT and surgery.

• Fluorouracil (5-FU) 500 mg/m2 IV bolus once per day on days 1 to 5

28-day cycle x 4 cycles

References

1. 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 & Folinic acid

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Regimen

Study	Evidence	Comparator
Hong et al. 2014 (ADORE)	Randomized Phase II	FOLFOX

Treatment preceded by fluoropyrimidine-based chemoradiation and total mesorectal excision.

• 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 x 4 cycles

References

1. 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

Fluorouracil, Folinic acid, Levamisole

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Regimen, Haller et al. 2005 (Intergroup 0089)

Level of Evidence: Phase III

Not in routine use; used as a comparator arm and here for reference purposes only.

• Folinic acid (Leucovorin) 20 mg/m2 IV push before 5-FU on days 1 to 5
• Fluorouracil (5-FU) 425 mg/m2 IV push on days 1 to 5
• Levamisole (Ergamisol)

28-day cycles x 3 cycles, then 35-day cycles x 3 cycles

References

1. Haller DG, Catalano PJ, Macdonald JS, O'Rourke MA, Frontiera MS, Jackson DV, Mayer RJ. Phase III study of fluorouracil, leucovorin, and levamisole in high-risk stage II and III colon cancer: final report of Intergroup 0089. J Clin Oncol. 2005 Dec 1;23(34):8671-8. link to original article contains verified protocol PubMed

FOLFOX

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FOLFOX: FOLinic acid, Fluorouracil, OXaliplatin

Regimen

Study	Evidence	Comparator
Hong et al. 2014 (ADORE)	Randomized Phase II	Fluorouracil & 5-FU

Treatment preceded by fluoropyrimidine-based chemoradiation and total mesorectal excision.

• 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 x 8 cycles

References

1. 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

Adjuvant chemoradiation

Capecitabine -> Capecitabine & RT -> Capecitabine

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RT: Radiation Therapy

Regimen

Study	Evidence	Comparator
Hofheinz et al. 2012	Phase III	5-FU -> 5-FU & RT -> 5-FU

Prior to chemoradiation:

• Capecitabine (Xeloda) 1250 mg/m2 PO BID (2500 mg/m2/day) on days 1 to 14

21-day cycle x 2 cycles, followed by:

Chemoradiation

• 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:

• Capecitabine (Xeloda) 1250 mg/m2 PO BID (2500 mg/m2/day) on days 1 to 14

21-day cycle x 3 cycles

References

1. 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 -> Fluorouracil & RT -> Fluorouracil

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RT: Radiation Therapy

Regimen #1, Smalley et al. 2006

Level of Evidence: Phase III

Prior to chemoradiation:

• Fluorouracil (5-FU) 500 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles

Chemoradiation starting on day 57:

• 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

After chemoradiation:

• Fluorouracil (5-FU) 450 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles, to start 28 days after completion of chemoradiation

Regimen #2, Hofheinz et al. 2012

Level of Evidence: Phase III

Prior to chemoradiation:

• Fluorouracil (5-FU) 500 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles

Chemoradiation:

• Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion while radiation is being given
• Concurrent radiation therapy, 50.4 Gy total

After chemoradiation:

• Fluorouracil (5-FU) 500 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles

Regimen #3, Smalley et al. 2006

Level of Evidence: Phase III

Prior to chemoradiation:

• Fluorouracil (5-FU) 300 mg/m2/day IV continuous infusion on days 1 to 42

8-week course (2 weeks off of chemotherapy prior to chemoradiation)

Chemoradiation starting on day 57:

• 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

After chemoradiation:

• Fluorouracil (5-FU) 300 mg/m2/day IV continuous infusion on days 1 to 56

56-day course, to start 28 days after completion of chemoradiation

Regimen #4, Tepper et al. 1997 & Tepper et al. 2002

Level of Evidence: Phase III

Prior to chemoradiation:

• Fluorouracil (5-FU) 500 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles

Chemoradiation:

• 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

After chemoradiation:

• Fluorouracil (5-FU) 450 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles, to start 28 days after completion of chemoradiation

Regimen #5

Level of Evidence: Non-randomized

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

1. 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
2. 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
3. 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
4. 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
5. 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 Apr 12. [Epub ahead of print] link to original article contains verified protocol PubMed

Fluorouracil (5-FU), Folinic acid (Leucovorin), RT

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Regimen

Level of Evidence: Phase III

Prior to chemoradiation:

• Fluorouracil (5-FU) 425 mg/m2 IV bolus on days 1 to 5, given after Folinic acid (Leucovorin)
• Folinic acid (Leucovorin) 20 mg/m2 IV bolus on days 1 to 5, given before Fluorouracil (5-FU)

28-day cycles x 2 cycles

Chemoradiation:

• 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

After chemoradiation:

• Fluorouracil (5-FU) 380 mg/m2 IV bolus on days 1 to 5
• Folinic acid (Leucovorin) 20 mg/m2 IV bolus on days 1 to 5

28-day cycles x 2 cycles, to start 28 days after completion of chemoradiation

References

1. 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
2. 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 Colon cancer - Advanced or metastatic disease. The regimens listed by the NCCN, Rectal Cancer version 3.2012, are identical to the list for Colon Cancer version 2.2012, with the same references.