A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

Alberta Health services

Status and phase: Unknown; Phase 2

Conditions: Neoplasm Metastasis; Rectal Cancer

Treatments: Drug: Capecitabine; Procedure: Pelvic radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT00122291

Capecitabine Phase 2

16080

Details and patient eligibility

About

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Full description

The purpose of this trial is to study the efficacy of preoperative radiation therapy and capecitabine in locally advanced rectal cancer.

Enrollment: 66 estimated patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)