Back to resultsA Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
Primary Purpose
Rectal Cancer, Neoplasm Metastasis
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Capecitabine
Pelvic radiation
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring preoperative, chemotherapy, radiation therapy, rectal cancer, transmural rectal wall invasion, nodal metastasis
Eligibility Criteria
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
Sites / Locations
- Tom Baker Cancer Centre
Outcomes
Primary Outcome Measures
safety
response
Secondary Outcome Measures
Full Information
NCT ID
NCT00122291
First Posted
July 20, 2005
Last Updated
January 18, 2012
Sponsor
Alberta Health services
1. Study Identification
Unique Protocol Identification Number
NCT00122291
Brief Title
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
Official Title
A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alberta Health services
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Neoplasm Metastasis
Keywords
preoperative, chemotherapy, radiation therapy, rectal cancer, transmural rectal wall invasion, nodal metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Type
Procedure
Intervention Name(s)
Pelvic radiation
Primary Outcome Measure Information:
Title
safety
Title
response
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwyn Bebb, MD
Organizational Affiliation
Alberta Health services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer
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