Overview

This trial is active, not recruiting.

Conditions rectal cancer, neoplasm metastasis
Treatments capecitabine, pelvic radiation
Phase phase 2
Sponsor AHS Cancer Control Alberta
Start date January 2002
Trial size 66 participants
Trial identifier NCT00122291, 16080, Capecitabine Phase 2

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
safety
time frame:
response
time frame:

Eligibility Criteria

Male or female participants at least 17 years old.

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

Additional Information

Official title A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
Principal investigator Gwyn Bebb, MD
Description The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.