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NCT00122291 Clinical Trial

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

Rectal Cancer Clinical Trial

Official title:
A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00122291
Other study ID # 16080
Secondary ID Capecitabine Pha
Status Active, not recruiting
Phase Phase 2
First received July 20, 2005
Last updated January 18, 2012
Start date January 2002

Study information
Verified date August 2011
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 66
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 17 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• Capecitabine

Procedure:
• Pelvic radiation

Locations
Country Name City State
Canada Tom Baker Cancer Centre Calgary Alberta

Sponsors (1)
Lead Sponsor Collaborator
Alberta Health Services

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary safety
Primary response
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