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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.