Preoperative capecitabine and accelerated intensity-modulated radiotherapy in locally advanced rectal cancer: a phase II trial

Am J Clin Oncol. 2008 Jun;31(3):264-70. doi: 10.1097/COC.0b013e318161dbd3.


Objectives: A prospective phase II trial was conducted to evaluate the feasibility, safety, and pathologic response rate of preoperative capecitabine and accelerated synchronous integrated boost (SIB) intensity-modulated radiotherapy (IMRT) in patients with locally advanced rectal cancer.

Methods: Consenting operable patients with stage II or III adenocarcinoma of the rectum received capecitabine (825 mg/m2 PO BID, 5 days/wk x 5 weeks) and SIB-IMRT delivering 55 Gy (2.2 Gy/fraction) to the gross tumor while simultaneously delivering 45 Gy (1.8 Gy/fraction) to the regional lymph nodes and areas at risk for harboring microscopic disease. Total mesorectal excision followed 6 weeks later. A single pathologist analyzed the resected tumor's TNM stage and Mandard regression/response scores. The primary end point was pathologic complete response (pCR) rate.

Results: Ten subjects were enrolled, 2 of which were ineligible (1 screening failure and 1 unrelated cerebrovascular accident occurring early in treatment). The remaining 8 patients were evaluable. All 8 completed chemoradiation with strict compliance to the protocol schedule and then went on to surgical resection. At a median follow-up of 26 months (range, 15-40), all patients were alive without evidence of recurrent disease. The crude pCR rate was 38% with 50% achieving down-staging. Of 3 patients who had tumors within 5 cm of the anal verge, 2 underwent sphincter-sparing procedures. Grade 4 diarrhea occurred in 1 of 8 (13%) patients. The remaining toxicities were grade 1 or 2.

Conclusions: Preoperative chemoradiation with capecitabine and SIB-IMRT is well tolerated and results in an encouraging pCR rate for patients with locally advanced rectal cancer.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / pathology
  • Adenocarcinoma / surgery
  • Adenocarcinoma / therapy*
  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage
  • Capecitabine
  • Chemotherapy, Adjuvant
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Diarrhea / chemically induced
  • Disease-Free Survival
  • Feasibility Studies
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives*
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Premedication
  • Prospective Studies
  • Radiotherapy Dosage
  • Radiotherapy, Adjuvant
  • Radiotherapy, Intensity-Modulated*
  • Rectal Neoplasms / pathology
  • Rectal Neoplasms / surgery
  • Rectal Neoplasms / therapy*
  • Remission Induction


  • Antimetabolites, Antineoplastic
  • Deoxycytidine
  • Capecitabine
  • Fluorouracil