Preoperative combined modality therapy for clinically resectable uT3 rectal adenocarcinoma

Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):987-95. doi: 10.1016/s0360-3016(00)01529-7.


Purpose: To determine the acute toxicity, outcome, and sphincter preservation rates in patients with clinically resectable uT3 adenocarcinoma of the rectum treated with preoperative combined modality therapy.

Methods and materials: A total of 72 patients were treated from 12/90-7/98 with preoperative 50.4 Gy plus 2 cycles of concurrent 5-fluorouracil (5-FU) and leucovorin (LV) bolus daily x 5 followed by sharp or total mesorectal excision and 4 cycles of postoperative 5-FU and LV.

Results: Individual Grade 3+ toxicities during preoperative therapy included diarrhea, 11%; bowel movements, 9%; leukopenia, 18%; tenesmus, 1%; and thrombocytopenia, 1%. Total Grade 3+ toxicity was 28%. The pathologic complete response (CR) rate was 13%, and an additional 9% had a clinical CR for a total CR rate of 22%. Of the 35 patients who were judged clinically by their operating surgeon to require an abdominoperineal resection (APR) and were therefore treated with the goal of sphincter preservation, 89% were able to undergo sphincter-preserving surgery. Of the 21 patients eligible for analysis, 81% had good to excellent sphincter function. The 3-year actuarial patterns of failure were 2% local, 8% abdominal, and 13% distant. The 3-year actuarial survival was 95%.

Conclusions: Our data confirm our preliminary reports of encouraging rates of acute toxicity, local control, survival, sphincter preservation and function with preoperative combined modality therapy. It is an alternative approach for the treatment of uT3 clinically resectable rectal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / radiotherapy*
  • Adenocarcinoma / surgery
  • Anal Canal / surgery
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antimetabolites, Antineoplastic / adverse effects
  • Combined Modality Therapy
  • Disease-Free Survival
  • Fluorouracil / administration & dosage*
  • Fluorouracil / adverse effects
  • Follow-Up Studies
  • Humans
  • Leucovorin / administration & dosage
  • Neoplasm Staging
  • Preoperative Care
  • Radiotherapy Dosage
  • Rectal Neoplasms / drug therapy*
  • Rectal Neoplasms / radiotherapy*
  • Rectal Neoplasms / surgery
  • Treatment Failure


  • Antimetabolites, Antineoplastic
  • Leucovorin
  • Fluorouracil