Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy in Treating Patients Who Are Undergoing Surgical Resection for Locally Advanced Rectal Cancer

Exclusion Criteria

• •1. Any evidence of distant metastasis
• •2. Synchronous primary colon carcinomas, except T1 lesions (full colonoscopy not required for enrollment)
• •3. Extension of malignant disease to the anal canal
• •4. Prior radiation therapy to the pelvis
• •5. Prior chemotherapy for malignancies
• •6. Pregnancy or lactation, (exclusion due to potential adverse effects of therapy). Women of childbearing potential with either a positive or no pregnancy test (serum or urine) at baseline. Women/men of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered to be of non-childbearing potential.) Patients will agree to continue contraception for 30 days from the date of the last study drug administration.
• •7. Serious, uncontrolled, concurrent infection(s).
• •8. Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
• •9. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
• •10. Evidence 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 of oral drug intake.
• •11. Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
• •12. Major surgery within 4 weeks of the study treatment.
• •13. Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• •14. Known, existing uncontrolled coagulopathy.
• •15. No concurrent cimetidine allowed.