Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma

Colorectal Cancer Clinical Trial

Official title: An Open Label, Phase II Study of Capecitabine (Xeloda) Plus Conformal Radiotherapy for Patients With Locally Advanced, Non-Metastatic Rectosigmoid Carcinoma

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Patients will all receive the combined treatment of 3-D external radiation therapy plus Xeloda®. External Radiation Therapy to the pelvis, lower abdomen and rectal area will be given once a day, five days a week, Monday through Friday, for about five to six weeks using three dimensional techniques.

Xeloda® (oral chemotherapy) is a pill taken by mouth. This medication will be taken during the course of radiation therapy on days that radiation treatments are given. Xeloda pills will be taken twice daily beginning with the first day of radiation therapy treatments and ending on the last day of radiation therapy treatment.

The following tests and procedures are part of regular medical treatment (standard care) for the disease and are also required for this study:

• physical examinations, sometimes including a digital rectal exam

• blood tests including a (blood) pregnancy test will be done before starting treatment if the patient is a woman able to have children.

• urinalysis

• ECG (heart tracing)

• chest X-ray

• ultrasound, which produces pictures of the rectal area using sound waves· CT scan of the pelvis and abdomen

Some people may need surgery, others may require more chemotherapy, and others may require no additional treatment depending on how their tumor responded to the Xeloda® and radiation therapy treatments.

Patients will also be asked to complete two questionnaires about their fatigue, general quality of life, and bowel functioning. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

• NCT number: NCT00216424
• Study type: Interventional
• Source: James A. Haley Veterans Administration Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: February 2005
• Completion date: January 2007