A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer

An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is < 3 months, and the target sample size is < 100 individuals.

Inclusion Criteria:

• adult patients, 18-80 years of age;
• rectal cancer;
• planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:

• previous radiotherapy or chemotherapy for colorectal cancer;
• clinically significant cardiovascular disease;
• significant gastric or small intestine disease;
• serious uncontrolled active infection