Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085163
Status:
COMPLETED
Last Update Posted:
2015-10-20
First Post:
2004-06-10
Brief Title:
Celecoxib Combined With Fluorouracil and Leucovorin in Treating Patients With Resected Stage III Adenocarcinoma Cancer of the Colon
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Multicenter Double-Blind Placebo-Controlled Randomized Phase III Study of Adjuvant Therapy With Celecoxib in Combination With Chemotherapy in Patients With Curatively Resected Stage III Colon Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
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 such as fluorouracil and leucovorin work in different ways to stop tumor cells from dividing so they stop growing or die Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth It is not yet known whether fluorouracil and leucovorin are more effective with or without celecoxib in treating resected stage III adenocarcinoma cancer of the colon
PURPOSE This randomized phase III trial is studying celecoxib fluorouracil and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer
PURPOSE This randomized phase III trial is studying celecoxib fluorouracil and leucovorin to see how well they work compared to fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer
Detailed Description:
OBJECTIVES
Primary
Compare disease-free survival of patients with curatively resected stage III adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium with or without celecoxib
Secondary
Compare the overall survival the occurrence of new primary colon cancer and the development of new polyps in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to 4 tumor-positive lymph nodes yes vs no form of adjuvant chemotherapy infusional vs bolus low-dose aspirin for cardiovascular prophylaxis yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil and leucovorin calcium IV for up to 6 courses in the absence of disease recurrence or unacceptable toxicity Patients also receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily and fluorouracil and leucovorin calcium as in arm I
In both arms treatment with celecoxib or placebo continues for 3 years in the absence of disease recurrence or unacceptable toxicity
Patients are followed annually for 2 years
PROJECTED ACCRUAL A total of 1450 patients 725 per treatment arm will be accrued for this study within 2 years
Primary
Compare disease-free survival of patients with curatively resected stage III adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium with or without celecoxib
Secondary
Compare the overall survival the occurrence of new primary colon cancer and the development of new polyps in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to 4 tumor-positive lymph nodes yes vs no form of adjuvant chemotherapy infusional vs bolus low-dose aspirin for cardiovascular prophylaxis yes vs no and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive fluorouracil and leucovorin calcium IV for up to 6 courses in the absence of disease recurrence or unacceptable toxicity Patients also receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily and fluorouracil and leucovorin calcium as in arm I
In both arms treatment with celecoxib or placebo continues for 3 years in the absence of disease recurrence or unacceptable toxicity
Patients are followed annually for 2 years
PROJECTED ACCRUAL A total of 1450 patients 725 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| PETACC-5 | None | None | None |
| EORTC-40023 | None | None | None |