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

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.

• Authors: Adalsteinn Gunnlaugsson, Harald Anderson, Eva Fernebro, Elisabeth Kjellén, Per Byström, Ke Berglund, Mats Ekelund, Lars Påhlman, Torbjörn Holm, Bengt Glimelius, Anders Johnsson
• Journal: European journal of cancer (Oxford, England : 1990) (Eur J Cancer) Vol. 45 Issue 5 Pg. 807-13 (Mar 2009) ISSN: 1879-0852 [Electronic] England
• PMID: 19110416 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Oxaloacetates
• Deoxycytidine
• Capecitabine
• Fluorouracil

Topics

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