Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00232453
First received: October 3, 2005
Last updated: February 11, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Rectal Neoplasms
Procedure: Combined Radiation and Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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

Estimated Enrollment: 34
Study Start Date: March 2001
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232453

Locations
Canada, Ontario
University Health Network Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: James Brierley, MD Princess Margaret Hospital, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232453     History of Changes
Other Study ID Numbers: UHN REB 01-0024-C
Study First Received: October 3, 2005
Last Updated: February 11, 2011
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on April 17, 2014