A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

Phase 2

• Conditions: Rectal Cancer; Neoplasm Metastasis

• Registration Number: NCT00122291
• Lead Sponsor: Alberta Health services

Brief Summary

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Detailed Description

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2005-07-20
• Study First Submitted QC: 2005-07-20
• Study First Posted: 2005-07-22
• Status Verified: 2011-08
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Biopsy - proven rectal cancer
• Transmural rectal wall invasion
• Karnofsky performance status >70
• Normal bone marrow, liver and kidney function

Exclusion Criteria

• Distant metastases
• Prior pelvic radiation
• Inflammatory bowel disease
• Severe ischemic heart disease
• Anticoagulant therapy
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
safety
response

Trial Locations

Locations (1)

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada