Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004931
Status:
COMPLETED
Last Update Posted:
2013-01-14
First Post:
2000-03-07
Brief Title:
Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Clinical Trial Comparing 5-Fluorouracil 5-FU Plus Leucovorin LV and Oxaliplatin With 5-FU Plus LV for the Treatment of Patients With Stages II and III Carcinoma of the Colon
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer 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 which combination chemotherapy regimen is more effective for colon cancer
Detailed Description:
PRIMARY OBJECTIVES
I To compare the relative efficacy of 5-FU LV Oxaliplatin FLOX with that of 5-FU LV FL in prolonging DFS
SECONDARY OBJECTIVES
I To compare the relative efficacy of FLOX with FL in prolonging S
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
ARM I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV administered after 1 hour of leucovorin calcium weekly for 6 weeks
ARM II Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and leucovorin calcium and fluorouracil as in arm I
Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 6 9 and 12 months every 6 months for 4 years and then annually thereafter
I To compare the relative efficacy of 5-FU LV Oxaliplatin FLOX with that of 5-FU LV FL in prolonging DFS
SECONDARY OBJECTIVES
I To compare the relative efficacy of FLOX with FL in prolonging S
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms
ARM I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV administered after 1 hour of leucovorin calcium weekly for 6 weeks
ARM II Patients receive oxaliplatin IV over 2 hours on days 1 15 and 29 and leucovorin calcium and fluorouracil as in arm I
Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 6 9 and 12 months every 6 months for 4 years and then annually thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA012027 | NIH | None | httpsreporternihgovquickSearchU10CA012027 |
| NSABP-C-07 | None | None | None |