Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
This study has been completed.
Sponsor:
Institute of Cancer Research, United Kingdom
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005586
First received: May 2, 2000
Last updated: December 17, 2013
Last verified: March 2007
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Purpose
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 |
|---|---|---|
|
Colorectal Cancer |
Drug: L-leucovorin Drug: fluorouracil Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- All-cause mortality [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Death from colorectal cancer [ Designated as safety issue: No ]
- Disease recurrence [ Designated as safety issue: No ]
| Estimated Enrollment: | 2500 |
| Study Start Date: | October 1997 |
OBJECTIVES:
- Compare all-cause mortality in patients with resected colorectal cancer treated with adjuvant chemotherapy with L-leucovorin and fluorouracil vs observation.
- Compare the recurrence rates in patients treated with this regimen vs observation.
- Compare the effectiveness of a monthly 5-day schedule vs a once weekly schedule of L-leucovorin and fluorouracil in this patient population.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to receive adjuvant chemotherapy (arm I) or undergo observation only (arm II).
- Arm I: Within 12 weeks of surgery, patients receive L-leucovorin IV followed by fluorouracil IV on days 1-5 every 4 weeks for 6 courses. Alternatively, patients may receive L-leucovorin IV followed by fluorouracil IV on day 1 weekly for 30 weeks.
- Arm II: Patients undergo observation. Patients are followed annually.
PROJECTED ACCRUAL: A total of 2,500 patients (1,250 per arm) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Completely resected stage II or III colorectal cancer
- No distant metastases
- No positive resection margins
- No positive peritoneal washings
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No clear definite indication for, or contraindication against, systemic chemotherapy with L-leucovorin and fluorouracil
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No concurrent chemotherapy in observation only arm
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent radiotherapy allowed in adjuvant chemotherapy arm provided chemotherapy administered on the once weekly schedule
Surgery:
- See Disease Characteristics
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005586
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005586
Locations
| United Kingdom | |
| Royal London Hospital | |
| London, England, United Kingdom, E1 1BB | |
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
| Study Chair: | Norman Williams, MD | Royal London Hospital |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00005586 History of Changes |
| Other Study ID Numbers: | CDR0000067660, NCRI-QUASAR1, EU-99053, UKCCCR-QUASAR1, ISRCTN82375386 |
| Study First Received: | May 2, 2000 |
| Last Updated: | December 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II colon cancer stage III colon cancer stage II rectal cancer stage III rectal cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases |
Fluorouracil Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015