Preoperative Combined Radiation and Chemotherapy - Rectal Cancer
February 11, 2011 updated by: University Health Network, Toronto
A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer
There is no established standard preoperative treatment in rectal cancer.
Two large randomized studies in North America closed from lack of accrual; therefore the only method of assessing preoperative treatment in rectal cancer is from Phase II studies.
This study builds on the experience at PMH gained in two previous studies which demonstrated a lower than expected toxicity with concurrent 5FU infusion and external radiotherapy.
The current standard at PMH is preoperative radiation, 46Gy in 23 fractions with concurrent 5FU infusion 225mg/m2.
An increase of radiation dose and consequent increase in chemotherapy may improve the response rate, but may also increase toxicity.
It is proposed to increase the dose of radiotherapy to 50Gy in 25 fractions with concurrent chemotherapy and measure acute toxicity and complete remission rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network Princess Margaret Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Biopsy proven adenocarcinoma of the rectum
- Performance status <2 (ECOG, appendix II)
- Clinical Stage T2 N1-2, T3-4 NO-2, without evidence of distant metastasis
Exclusion Criteria:
- Prior pelvic irradiation
- Inflammatory bowel disease
- Evidence of distant metastasis
- Performance status >2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: James Brierley, MD, Princess Margaret Hospital, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2001
Primary Completion (Actual)
December 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
October 3, 2005
First Submitted That Met QC Criteria
October 3, 2005
First Posted (Estimate)
October 4, 2005
Study Record Updates
Last Update Posted (Estimate)
February 15, 2011
Last Update Submitted That Met QC Criteria
February 11, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN REB 01-0024-C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.