drugset / Trial / NCT00216424
Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma
Phase 4
Terminated
40 enrolled
James A. Haley Veterans Administration Hospital
Hoffmann-La Roche · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is designed primarily to establish efficacy and estimate resource utilization. The short-term hypothesis is that the dose of capecitabine (825 mg/m2 twice/day 5 days per week) during the course of radiation therapy is efficacious in locally advanced, non-metastatic rectosigmoid carcinoma and will improve resectability. The long-term working hypothesis is that if 3-D CRT is combined with the potentiating and additive effect of capecitabine one hopes to see improved and durable tumor response and survival with acceptable toxicity. In addition, it is expected that the simplicity of using an oral agent (capecitabine) will be associated with reduced cost and resource utilization.
Timeline
- Start
- 2005-02
- Primary completion
- —
- Completion
- 2007-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 825 mg/m2 | Oral |