Multicentre phase II trial of capecitabine and oxaliplatin in combination with radiotherapy for unresectable colorectal cancer: the CORGI-L Study

Eur J Cancer. 2009 Mar;45(5):807-13. doi: 10.1016/j.ejca.2008.11.017. Epub 2008 Dec 26.

Abstract

Aims: This study assessed radiotherapy combined with capecitabine and oxaliplatin in patients with primary, inextirpable colorectal adenocarcinoma.

Patients and methods: Forty-nine patients entered the trial. Two cycles of XELOX (capecitabine 1000 mg/m(2) bid d1-14+oxaliplatin 130 mg/m(2) d1, q3w) were followed by radiotherapy (50.4 Gy), combined with capecitabine 825 mg/m(2) bid every radiotherapy day and oxaliplatin 60 mg/m(2) once weekly. The primary end-point was objective response.

Results: Forty-seven patients were evaluable. Twenty-nine (62% [95% CI: 46-75%]) achieved complete or partial response. Thirty-eight (81%) went through surgery of whom 37 (97%) had an R0 resection and five (13%) had a pathological complete response. Seventy-eight percent were alive and estimated local progression rate was 11% at 2 years. The most common grade 3+ toxicity during chemoradiotherapy was diarrhoea (24%).

Conclusions: XELOX-RT was feasible and showed promising efficacy when treating patients with primary inextirpable colorectal cancer, establishing high local control rate.

Publication types

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

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adenocarcinoma / radiotherapy
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Capecitabine
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / pathology
  • Colorectal Neoplasms / radiotherapy
  • Combined Modality Therapy / methods
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Fluorouracil / analogs & derivatives
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Oxaloacetates
  • Patient Compliance
  • Patient Selection
  • Radiotherapy, High-Energy
  • Survival Analysis
  • Treatment Outcome

Substances

  • Oxaloacetates
  • Deoxycytidine
  • Capecitabine
  • Fluorouracil

Supplementary concepts

  • XELOX