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Home > "L" Clinical Trials Conditions > Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed  Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
For Condition: stage 2 colon cancer,stage 3 rectal cancer,stage 2 rectal cancer,stage 3 colon cancer
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) ,
Synopsis: 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: Randomizedphase III trial to compare the effectiveness of leucovorin and fluorouracil with that of observation in treating patients who have colorectal cancer that has been surgically removed.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NormanWilliams, Study Chair, Royal London Hospital
Royal London Hospital *Recruiting*
London, England, E1 1BB
United Kingdom
Recruiting Norman Williams 44-20-7377-7079
Additional Information:
Study ID Numbers: CDR0000067660; UKCCCR-QUASAR1,NCRI-QUASAR1,EU-99053
Study Start Date:
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005586
Other Stage 3 Colon Cancer Studies:
1. High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
2. Lymph Node Mapping and Sentinel Lymph Node Biopsy in Patients With Stage I, Stage II, or Stage III Colorectal Cancer
3. Gemcitabine in Treating Patients With Advanced Colorectal Cancer
4. Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer
5. Combination Chemotherapy in Treating Patients With Colorectal Cancer
Related Studies:
Other stage 3 colon cancer Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
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