Leucovorin and Fluorouracil With or Without Oxaliplatin Compared to Capecitabine With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
NCT00070213 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2021-09-27
Summary
RATIONALE: Drugs used in chemotherapy, such as leucovorin, fluorouracil, capecitabine, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether leucovorin and fluorouracil with or without oxaliplatin is more effective than capecitabine with or without oxaliplatin in treating patients who have metastatic colorectal cancer.
PURPOSE: This randomized phase III trial is studying four different chemotherapy regimens to compare how well they work in treating patients with metastatic colorectal cancer.
Conditions
Interventions
- DRUG
-
FOLFOX regimen
- DRUG
- DRUG
- DRUG
-
leucovorin calcium
- DRUG
- PROCEDURE
-
quality-of-life assessment
Sponsors & Collaborators
-
University of Leeds
collaborator OTHER - lead OTHER_GOV
Principal Investigators
-
Matthew T. Seymour, MA, MD, FRCP · Cookridge Hospital
-
Gareth Griffiths · Medical Research Council
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 0 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-09-30
- Primary Completion
- 2011-06-01
- Completion
- 2011-06-01
Countries
- United Kingdom
Study Locations
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