Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00268398
Status:
COMPLETED
Last Update Posted:
2012-05-22
First Post:
2005-12-20
Brief Title:
Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Overview
Official Title:
Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables DOrigine Colorectale - MIROX
Status:
COMPLETED
Status Verified Date:
2012-05
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:
MIROX
Brief Summary:
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases
Detailed Description:
OBJECTIVES
Primary
Compare the 2-year disease-free survival rate in patients treated with these regimens
Secondary
Compare the overall survival of patients treated with these regimens
Compare the tolerability of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the objective response rate postoperative complication rate and transfusing rate in patients having metastasis surgery
Determine the pharmacogenetics of these regimens in these patients
OUTLINE This is a randomized open-label multicenter phase III study Patients are stratified according to prior chemotherapy perioperative vs postoperative prior treatment surgery only vs radiotherapy with or without surgery and Blumgart score 0-1 vs 2-3 vs 4-5 Patients are randomized to 1 of 2 treatment arms
Arm I FOLFOX 4 Patients receive FOLFOX 4 combination chemotherapy comprising oxaliplatin 85mgm² IV over 2 hours leucovorin calcium IV over 2 hours fluorouracil IV bolus 15min and fluorouracil continuously over 22 hours on day 1 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
Arm II FOLFOX 7 and FOLFIRI Patients receive FOLFOX 7 combination chemotherapy comprising high-dose oxaliplatin 130mgm² IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients then receive FOLFIRI combination chemotherapy comprising irinotecan hydrochloride 180mgm² IV over 30-90 minutes and leucovorin calcium and fluorouracil IV bolus 15min on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients in both arms who have undergone prior resection of metastatic lesions may undergo surgery after 6 courses of chemotherapy or after chemotherapy is completed
Quality of life is assessed at baseline and after courses 4 8 and 12
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 284 patients will be accrued for this study
Primary
Compare the 2-year disease-free survival rate in patients treated with these regimens
Secondary
Compare the overall survival of patients treated with these regimens
Compare the tolerability of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Compare the objective response rate postoperative complication rate and transfusing rate in patients having metastasis surgery
Determine the pharmacogenetics of these regimens in these patients
OUTLINE This is a randomized open-label multicenter phase III study Patients are stratified according to prior chemotherapy perioperative vs postoperative prior treatment surgery only vs radiotherapy with or without surgery and Blumgart score 0-1 vs 2-3 vs 4-5 Patients are randomized to 1 of 2 treatment arms
Arm I FOLFOX 4 Patients receive FOLFOX 4 combination chemotherapy comprising oxaliplatin 85mgm² IV over 2 hours leucovorin calcium IV over 2 hours fluorouracil IV bolus 15min and fluorouracil continuously over 22 hours on day 1 Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity
Arm II FOLFOX 7 and FOLFIRI Patients receive FOLFOX 7 combination chemotherapy comprising high-dose oxaliplatin 130mgm² IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients then receive FOLFIRI combination chemotherapy comprising irinotecan hydrochloride 180mgm² IV over 30-90 minutes and leucovorin calcium and fluorouracil IV bolus 15min on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients in both arms who have undergone prior resection of metastatic lesions may undergo surgery after 6 courses of chemotherapy or after chemotherapy is completed
Quality of life is assessed at baseline and after courses 4 8 and 12
After completion of study treatment patients are followed periodically for 5 years
PROJECTED ACCRUAL A total of 284 patients will be accrued for this study
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 |
|---|---|---|---|
| GERCOR-C02-1 | None | None | None |
| GERCOR-C02-1-MIROX | None | None | None |
| EU-20567 | None | None | None |
| SANOFI-GERCOR-C02-1 | None | None | None |