Trial Information
A Phase 2 Study of Preoperative Radiation Therapy and Capecitabine (an Oral Fluoropyrimidine Carbamate) in Locally Advanced Rectal Cancer
The purpose of this trial is to study the efficacy of preoperative radiation therapy and
capecitabine in locally advanced rectal cancer.
Inclusion Criteria:
- Biopsy - proven rectal cancer
- Transmural rectal wall invasion
- Karnofsky performance status >70
- Normal bone marrow, liver and kidney function
Exclusion Criteria:
- Distant metastases
- Prior pelvic radiation
- Inflammatory bowel disease
- Severe ischemic heart disease
- Anticoagulant therapy
- Pregnancy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
safety
Principal Investigator
Gwyn Bebb, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Alberta Health Services
Authority:
Canada: Health Canada
Study ID:
16080
NCT ID:
NCT00122291
Start Date:
January 2002
Completion Date:
Related Keywords:
- Rectal Cancer
- Neoplasm Metastasis
- preoperative
- chemotherapy
- radiation therapy
- rectal cancer
- transmural rectal wall invasion
- nodal metastasis
- Neoplasms
- Rectal Neoplasms
- Neoplasm Metastasis