Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232453
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : February 15, 2011
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Neoplasms Procedure: Combined Radiation and Chemotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer
Study Start Date : March 2001
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Primary Outcome Measures :
  1. Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232453

Canada, Ontario
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: James Brierley, MD Princess Margaret Hospital, Canada Identifier: NCT00232453     History of Changes
Other Study ID Numbers: UHN REB 01-0024-C
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases