Oxaliplatin in Rectal Cancer

Phase I-II Study of Preoperative Oxaliplatin-FU and Radiotherapy for Patients With Rectal Cancer

• Phase I: To determine the maximum tolerated dose, and recommended dose of the proposed doses of oxaliplatin in this study
• Phase II: To determine the treatment efficacy according to response rates from phase I.

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main criteria are listed hereafter:

Inclusion Criteria:

• ECOG: 0-2
• Histological proved rectal adenocarcinoma
• No chemotherapy treatment on the previous 6 months before inclusion.
• No previous pelvic radiotherapy treatment

Exclusion Criteria:

• Important Biological abnormality (renal, hepatic and/or hematological)
• Intestinal occlusion or subocclusion
• Peripheral neuropathy
• Pregnant or breast-feeding women. Potential child-bearing women with a positive pregnancy test.
• Participation in other trials on the previous 4 months.