Multicentre phase II trial of capecitabine and oxaliplatin in combination with radiotherapy for unresectable colorectal cancer: the CORGI-L Study.
OBJECTIVE
This study assessed radiotherapy combined with capecitabine and oxaliplatin in patients with primary, inextirpable colorectal adenocarcinoma.


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.
Gunnlaugsson
Adalsteinn
A
Department of Oncology, Lund University Hospital, Lasarettsgatan, Lund, Sweden. adalsg@hotmail.com
Anderson
Harald
H
Fernebro
Eva
E
Kjellén
Elisabeth
E
Byström
Per
P
Berglund
Ke
K
Ekelund
Mats
M
Påhlman
Lars
L
Holm
Torbjörn
T
Glimelius
Bengt
B
Johnsson
Anders
A
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D003131:Combined Modality Therapy / Q000379:methods; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010071:Oxaloacetates; D010349:Patient Compliance; D018579:Patient Selection; D011882:Radiotherapy, High-Energy; D016019:Survival Analysis; D016896:Treatment Outcome
D010071:Oxaloacetates; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil