Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
NCT ID: NCT00005586
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2500 participants
INTERVENTIONAL
1997-10-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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L-leucovorin
fluorouracil
adjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
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Norman Williams, MD
Role: STUDY_CHAIR
Royal London Hospital
Locations
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Royal London Hospital
London, England, United Kingdom
Countries
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References
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Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.
Other Identifiers
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NCRI-QUASAR1
Identifier Type: -
Identifier Source: secondary_id
EU-99053
Identifier Type: -
Identifier Source: secondary_id
UKCCCR-QUASAR1
Identifier Type: -
Identifier Source: secondary_id
ISRCTN82375386
Identifier Type: -
Identifier Source: secondary_id
CDR0000067660
Identifier Type: -
Identifier Source: org_study_id
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