Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005586
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2000-05-02
Brief Title:
Leucovorin and Fluorouracil Compared With Observation in Treating Patients With Colorectal Cancer That Has Been Surgically Removed
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A UKCCCR Study of Adjuvant Chemotherapy for Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 2500 patients 1250 per arm will be accrued for this study
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 2500 patients 1250 per arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN82375386 | None | None | None |
| NCRI-QUASAR1 | None | None | None |
| EU-99053 | None | None | None |
| UKCCCR-QUASAR1 | None | None | None |