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Capecitabine (Xeloda) and Radiation for Patients With Rectosigmoid Carcinoma

NCT00216424 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2007-11-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Capecitabine (Xeloda)

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • James A. Haley Veterans Administration Hospital

    lead FED

Principal Investigators

  • Ismail Kazem, MD · James A. Haley Veterans Administration Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Completion
2007-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216424 on ClinicalTrials.gov