A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rectal Neoplasms
Both
Rectal Neoplasms
Trial Information
A Phase II Protocol of Preoperative Combined Radiation and Chemotherapy for Resectable Primary Rectal Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess acute toxicity and complete remission rate of combined preoperative radiation and chemotherapy
Principal Investigator
James Brierley, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 01-0024-C
NCT ID:
NCT00232453
Start Date:
March 2001
Completion Date:
December 2004
Related Keywords:
- Rectal Neoplasms
- Neoplasms
- Rectal Neoplasms
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