Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer

Primary:

• To assess complete pathological response rate of both strategies.

Secondary:

• Safety profile
• To assess downstaging rate of both strategies.
• To compare relative dose intensity of oxaliplatin and capecitabine of both strategies
• To compare time to progression and overall survival of both strategies.

Inclusion Criteria:

• Patients with rectal adenocarcinoma.
• Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or,
• Rectal tumour at distal third, or
• Tumours spread more than 5 mm in perirectal fat
• Functional state ECOG ≤ 2.
• Good hematological, hepatic and renal function

Exclusion Criteria:

• Previous pelvis radiotherapy.
• Previous antitumoural chemotherapy
• Pregnant or breastfeeding women.
• Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months.
• History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer.
• Clinically significant cardiovascular disease
• Confirmed peripheral neuropathy.
• Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication.
• Blood disorders.
• Intercurrent non-controlled or severe infections.
• Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.