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
- 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
- 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
- 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.