Xeloda Maintenance Versus BSC in Metastatic Colorectal Cancer

• Histologically documented colorectal adenocarcinoma (chemo-naïve)
• Age over 18 years old
• Performance status (ECOG scale): 0-2
• Measurable or evaluable disease
• Adequate organ functions
• Life expectancy more than 3 months
• Patients should sign a written informed consent before study entry.

Exclusion Criteria:

• Tumor type other than adenocarcinoma
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin, papillary thyroid carcinoma or prior malignancy treated more than 5 years ago without recurrence)
• Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer.
• Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease is allowed if completed at least 6 months prior to initiation of study treatment.
• Prior radiotherapy is permitted if it was not administered to target lesions selected for this study, unless progression of the selected target lesions within the radiation portal is documented, and provided it has been completed at least 4 weeks before randomization.
• Presence of CNS metastasis
• Obvious peritoneal seeding or bowel obstruction disturbing oral intake
• Symptomatic peripheral neuropathy (NCI CTC v3.0 Grade I)
• Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. Prior palliative surgical treatment of stage IV disease is permitted. The patient without measurable lesion(s) by operation or RFA is not eligible.
• Serious illness or medical conditions, as follows;congestive heart failure (NYHA class III or IV), unstable angina or myocardial infarction within the past 6 months, significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block,uncontrolled hypertension hepatic cirrhosis( above Child class B), interstitial pneumonia, pulmonary adenomatosis, psychiatric disorder that may interfere with and/or protocol compliance, unstable diabetes mellitus, uncontrolled ascites or pleural effusion active infection
• Receiving a concomitant treatment with drugs interacting with capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent, phenytoin, warfarin etc.
• Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
• Pregnant or lactating woman
• Women of child bearing potential not using a contraceptive method
• Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
• Any patients judged by the investigator to be unfit to participate in the study