Preoperative Combined Radiation and Chemotherapy - Rectal Cancer

Rectal Neoplasms Clinical Trial

Official title:

A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232453
• Other study ID #: UHN REB 01-0024-C
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2005
• Last updated: February 11, 2011
• Start date: March 2001
• Est. completion date: December 2004

Study information

• Verified date: February 2011
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Procedure:
• Combined Radiation and Chemotherapy

Locations

Country	Name	City	State
Canada	University Health Network Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy