Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031863
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2002-03-08
Brief Title:
Rofecoxib After Surgery in Treating Patients With Stage II or Stage III Colorectal Cancer
Sponsor:
Cancer Research Campaign Clinical Trials Centre
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Randomized Double Blind Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
Status:
COMPLETED
Status Verified Date:
2002-06
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 Rofecoxib may stop the growth of cancer by stopping blood flow to the tumor and killing tumor cells that remain after surgery It is not yet known if rofecoxib is effective in treating colorectal cancer
PURPOSE Randomized phase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer
PURPOSE Randomized phase III trial to determine the effectiveness of giving rofecoxib after surgery in treating patients who have stage II or stage III colorectal cancer
Detailed Description:
OBJECTIVES
Compare the overall survival of patients with previously resected stage II or III colorectal cancer treated with rofecoxib vs placebo administered for at least 2 years vs 5 years
Compare the relapse-free survival of patients treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to participating center site of disease colon vs rectum disease stage II vs III age adjuvant chemotherapy yes vs no and type of chemotherapy regimen 1 vs 2 vs 3 vs 4 vs 5 Within 3 months of surgical resection alone or completion of adjuvant radiotherapy andor chemotherapy after surgical resection patients are randomized to one of four treatment arms
Arm I Patients receive oral rofecoxib once daily for 2 years
Arm II Patients receive oral rofecoxib once daily for 5 years
Arm III Patients receive oral placebo once daily for 2 years
Arm IV Patients receive oral placebo once daily for 5 years Treatment continues in all arms in the absence of disease recurrence or unacceptable toxicity
PROJECTED ACCRUAL A total of 7000 patients 1750 per treatment arm will be accrued for this study within 5 years
Compare the overall survival of patients with previously resected stage II or III colorectal cancer treated with rofecoxib vs placebo administered for at least 2 years vs 5 years
Compare the relapse-free survival of patients treated with these regimens
OUTLINE This is a randomized placebo-controlled double-blind multicenter study Patients are stratified according to participating center site of disease colon vs rectum disease stage II vs III age adjuvant chemotherapy yes vs no and type of chemotherapy regimen 1 vs 2 vs 3 vs 4 vs 5 Within 3 months of surgical resection alone or completion of adjuvant radiotherapy andor chemotherapy after surgical resection patients are randomized to one of four treatment arms
Arm I Patients receive oral rofecoxib once daily for 2 years
Arm II Patients receive oral rofecoxib once daily for 5 years
Arm III Patients receive oral placebo once daily for 2 years
Arm IV Patients receive oral placebo once daily for 5 years Treatment continues in all arms in the absence of disease recurrence or unacceptable toxicity
PROJECTED ACCRUAL A total of 7000 patients 1750 per treatment arm will be accrued for this study within 5 years
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 |
|---|---|---|---|
| NCCTG-N004B | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000069235 | REGISTRY | None | None |
| EU-20054 | None | None | None |
| CRC-TU-COX2 | None | None | None |
| ISRCTN98278138 | None | None | None |