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

Roche

Status and phase: Completed; Phase 2

Conditions: Colorectal Cancer

Treatments: Drug: Capecitabine [Xeloda]; Radiation: Standard radiotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00796718

ML21800

2008-003980-38

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Capecitabine

Experimental group

Description:

Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment.

Treatment:

Drug: Capecitabine [Xeloda]

Radiation: Standard radiotherapy