Surgery With or Without Chemotherapy and Radiation Therapy in TreatingPatients With Stage I Rectal Cancer
NCT00023751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2016-07-06
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining surgery with chemotherapy and radiation therapy may kill more tumor cells and prevent recurrence of the cancer.
PURPOSE: Phase II trial to study the effectiveness of surgery with or without chemotherapy and radiation therapy in treating patients who have stage I rectal cancer.
Conditions
Interventions
- DRUG
- DRUG
-
leucovorin calcium
- PROCEDURE
-
conventional surgery
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Ronald Bleday, MD · Dana-Farber/Brigham and Women's Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-07-31
- Primary Completion
- 2004-04-30
- Completion
- 2004-04-30
Countries
- United States
- Canada
- Puerto Rico
Study Locations
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