NCT00176787

Radiation Therapy With Capecitabine in Rectal Cancer

Phase II Trial of Preoperative Radiation Therapy With Capecitabine in Rectal Cancer (UMCC 0046)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will use an experimental combination of treatment with the drug Capecitabine and radiation therapy prior to an operation for removal of the patient's tumor. The drug Capecitabine is an oral form of a drug called 5-FU which has been widely used to treat rectal cancer. This is a phase II clinical trial, which means that the physician will be studying the reactions of the patient's body and tumor to treatment with Capecitabine and radiation therapy. The purpose of this study is to see if the tumor responds to this treatment and to determine how long the response lasts. The study also will see what kind of side effects this experimental treatment causes and see how often these side effects occur. Preliminary human studies using Capecitabine and radiation therapy have produced encouraging results with acceptable side effects.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine
PROCEDURE	Radiation
PROCEDURE	Surgery

Timeline

• Start date: 2000-10-01
• Primary completion: 2005-05-01
• Completion: 2007-06-01
• First posted: 2005-09-15
• Last updated: 2008-01-10

Locations

1 site across 1 country: United States