Preoperative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer

Inclusion Criteria: * ECOG performance status score 0-1. * Chemo-naïve patients. * Histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mT3 or mT4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely. * Evaluable measurable disease on imaging with MRI/CT to allow for response assessment. * Adequate haematological, renal and liver functions as follows: * ANC \> 3000ml * Platelet count \> 100,000 ml * Urea \& Serum Creatinine \< 1.5 X upper limit of normal value * Total serum bilirubin \< 1.5 X upper limit of normal value * ALT \& AST \< 3 X upper limit of normal value Exclusion Criteria: * Prior chemotherapy. * Documented allergy to oxaliplatin or capecitabine. * Prior radiotherapy to pelvis. * Previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin. * Pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients). * Currently participating into another clinical trial with any investigational drug in the previous 30 days. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.