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

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

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

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