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

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.