A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the pathological complete tumor response rate.

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

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Sanofi-Synthélabo (Schweiz) AG
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor

• Eastern Cooperative Oncology Group performance status 0-2

• Adequate values of laboratory parameters

Exclusion Criteria:

• Evidence of distant metastases

• Previous Chemotherapy or immunotherapy for colorectal cancer

• Previous radiotherapy to the pelvis

• Pre-existing condition which would deter radiotherapy

• Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix

• Clinically significant cardiac disease or myocardial infarction within the last 12 months

• Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome

• Organ allografts

• Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues

• Dihydropyrimidine dehydrogenase (DPD) deficiency

• History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake