Rectal cancer - null regimens

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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 rectal cancer page for regimens that include active anticancer treatment.


Neoadjuvant therapy

No neoadjuvant therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Oates et al. 1996 1981-1989 Phase 3 (C) RT Seems to have inferior DFS
Cedermark et al. 1997 (Swedish Rectal Cancer Trial) 1987-1990 Phase 3 (C) RT Inferior OS
Kapiteijn et al. 2001 1996-1999 Phase 3 (C) RT Inferior local recurrence rate

No neoadjuvant therapy.

References

  1. Oates GD, Stenning SP, Hardcastle JD; Medical Research Council Rectal Cancer Working Party. Randomised trial of surgery alone versus radiotherapy followed by surgery for potentially operable locally advanced rectal cancer. Lancet. 1996 Dec 14;348(9042):1605-10. link to original article PubMed
  2. Swedish Rectal Cancer Trial: Cedermark B, Dahlberg M, Glimelius B, Påhlman L, Rutqvist LE, Wilking N; Swedish Rectal Cancer Trial investigators. Improved survival with preoperative radiotherapy in resectable rectal cancer. N Engl J Med. 1997 Apr 3;336(14):980-7. Erratum in: N Engl J Med 1997 May 22;336(21):1539. link to original article PubMed
    1. Update: Folkesson J, Birgisson H, Pahlman L, Cedermark B, Glimelius B, Gunnarsson U. Swedish Rectal Cancer Trial: long lasting benefits from radiotherapy on survival and local recurrence rate. J Clin Oncol. 2005 Aug 20;23(24):5644-50. link to original article PubMed
  3. Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. link to original article PubMed

Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Mittelman et al. 1985 1975-1980 Phase 3 (C) 1. 5-FU & Semustine Not reported
2. 5-FU, Semustine, RT Inferior RFS
3. RT Not reported
Fisher et al. 1988 (NSABP R-01) 1977-1986 Phase 3 (C) 1. MOF Not reported
2. RT Did not meet efficacy endpoints of DFS/OS
Amott et al. 1996 1984-1989 Phase 3 (C) RT Inferior local recurrence rate
Sainato et al. 2014 (I-CNR-RT) 1992-2001 Phase 3 (C) FULV Did not meet primary endpoint of OS
Hamaguchi et al. 2010 (NSAS-CC) 1996-2001 Phase 3 (C) UFT Seems to have inferior OS
Breugom et al. 2014 (PROCTOR) 2000-2013 Phase 3 (C) FULV Did not meet primary endpoint of OS
Breugom et al. 2014 (SCRIPT) 2000-2013 Phase 3 (C) Capecitabine Did not meet primary endpoint of OS
Glynne-Jones et al. 2014 (Chronicle) 2004-2008 Phase 3 (C) XELOX Did not meet primary endpoint of DFS
Okuno et al. 2017 (JFMC38) 2011-2013 Phase 3 (C) UFT & PSK Did not meet primary endpoint of DFS

No further treatment after (neoadjuvant therapy) and surgery.

Preceding treatment

References

  1. Mittelman A, Holyoke ED, Stablein DM, Novak JW, Thomas PRM, Moertel CG, Weiland LH, Livstone EM, Bruckner HW, Knowlton AH; Gastrointestinal Tumor Study Group. Prolongation of the disease-free interval in surgically treated rectal carcinoma. N Engl J Med. 1985 Jun 6;312(23):1465-72. link to original article PubMed
  2. NSABP R-01: Fisher B, Wolmark N, Rockette H, Redmond C, Deutsch M, Wickerham DL, Fisher ER, Caplan R, Jones J, Lerner H, Gordon P, Feldman M, Cruz A, Legault-Poisson S, Wexler M, Lawrence W, Robidoux A. Postoperative adjuvant chemotherapy or radiation therapy for rectal cancer: results from NSABP protocol R-01. J Natl Cancer Inst. 1988 Mar 2;80(1):21-9. link to original article PubMed
  3. Amott SJ, Stenning SP, Hardcastle JD; Medical Research Council Rectal Cancer Working Party. Randomised trial of surgery alone versus surgery followed by radiotherapy for mobile cancer of the rectum. Lancet. 1996 Dec 14;348(9042):1610-4. link to original article PubMed
  4. NSAS-CC: Hamaguchi T, Shirao K, Moriya Y, Yoshida S, Kodaira S, Ohashi Y; NSAS-CC Group. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Cancer Chemother Pharmacol. 2011 Mar;67(3):587-96. Epub 2010 May 19. link to original article PubMed NCT00152230
  5. Chronicle: Glynne-Jones R, Counsell N, Quirke P, Mortensen N, Maraveyas A, Meadows HM, Ledermann J, Sebag-Montefiore D. Chronicle: results of a randomised phase III trial in locally advanced rectal cancer after neoadjuvant chemoradiation randomising postoperative adjuvant capecitabine plus oxaliplatin (XELOX) versus control. Ann Oncol. 2014 Jul;25(7):1356-62. Epub 2014 Apr 8. link to original article PubMed NCT00427713
  6. I-CNR-RT: Sainato A, Cernusco Luna Nunzia V, Valentini V, De Paoli A, Maurizi ER, Lupattelli M, Aristei C, Vidali C, Conti M, Galardi A, Ponticelli P, Friso ML, Iannone T, Osti FM, Manfredi B, Coppola M, Orlandini C, Cionini L. No benefit of adjuvant Fluorouracil Leucovorin chemotherapy after neoadjuvant chemoradiotherapy in locally advanced cancer of the rectum (LARC): Long term results of a randomized trial (I-CNR-RT). Radiother Oncol. 2014 Nov;113(2):223-9. Epub 2014 Nov 14. link to original article PubMed
  7. PROCTOR/SCRIPT: Breugom AJ, van Gijn W, Muller EW, Berglund Å, van den Broek CB, Fokstuen T, Gelderblom H, Kapiteijn E, Leer JW, Marijnen CA, Martijn H, Meershoek-Klein Kranenbarg E, Nagtegaal ID, Påhlman L, Punt CJ, Putter H, Roodvoets AG, Rutten HJ, Steup WH, Glimelius B, van de Velde CJ; Dutch Colorectal Cancer Group; Nordic Gastrointestinal Tumour Adjuvant Therapy Group. Adjuvant chemotherapy for rectal cancer patients treated with preoperative (chemo)radiotherapy and total mesorectal excision: a Dutch Colorectal Cancer Group (DCCG) randomized phase III trial. Ann Oncol. 2015 Apr;26(4):696-701. Epub 2014 Dec 5. link to original article PubMed ISRCTN36266738
  8. JFMC38: Okuno K, Aoyama T, Oba K, Yokoyama N, Matsuhashi N, Kunieda K, Nishimura Y, Akamatsu H, Kobatake T, Morita S, Yoshikawa T, Sakamoto J, Saji S. Randomized phase III trial comparing surgery alone to UFT + PSK for stage II rectal cancer (JFMC38 trial). Cancer Chemother Pharmacol. 2018 Jan;81(1):65-71. Epub 2017 Nov 1. link to original article link to PMC article PubMed
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