Pre-operative Radiotherapy/ Oxaliplatin/ Capecitabine Treatment For Unresectable Locally-advanced Rectal Cancer (PROCTFUL)
- 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
- 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.