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Sponsored by: |
Institute of Cancer Research, United Kingdom |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005586 |
RATIONALE: Drugs used in chemotherapy 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 chemotherapy is more effective than observation in patients who have had surgery to remove colorectal cancer.
PURPOSE: This randomized phase III trial is studying leucovorin and fluorouracil to see how well they work compared to observation in treating patients with colorectal cancer that has been surgically removed.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: L-leucovorin Drug: fluorouracil Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer |
Estimated Enrollment: | 2500 |
Study Start Date: | October 1997 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).
Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |
Royal London Hospital | |
London, England, United Kingdom, E1 1BB |
Study Chair: | Norman Williams, MD | Royal London Hospital |
Study ID Numbers: | CDR0000067660, NCRI-QUASAR1, EU-99053, UKCCCR-QUASAR1, ISRCTN82375386 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005586 History of Changes |
Health Authority: | United States: Federal Government |
stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Adjuvants, Immunologic Rectal Neoplasm Leucovorin Trace Elements |
Intestinal Diseases Immunosuppressive Agents Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Vitamins Fluorouracil Gastrointestinal Neoplasms Micronutrients Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Neoplasms by Site Therapeutic Uses Vitamins Micronutrients |
Digestive System Neoplasms Vitamin B Complex Growth Substances Adjuvants, Immunologic Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |