Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091312
Status:
UNKNOWN
Last Update Posted:
2009-02-09
First Post:
2004-09-07
Brief Title:
Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Phase III Intergroup Trial in Resected Stage 2 Dukes B Colon Cancer 6-Month Infusional 5FU-CPT11 - Folinic Acid Versus Observation - Determination of Biologic Predictive and Response Factors
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 irinotecan leucovorin and fluorouracil work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving them after surgery may kill any remaining tumor cells It is not yet known whether combination chemotherapy is more effective than observation alone in treating patients who have undergone surgery for colon cancer
PURPOSE This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer
PURPOSE This randomized phase III trial is studying irinotecan and fluorouracil with or without leucovorin to see how well they work compared to observation alone in treating patients who have undergone surgery for stage II colon cancer
Detailed Description:
OBJECTIVES
Primary
Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy
Secondary
Compare 8-year overall survival in patients treated with these regimens
Compare tolerability of these regimens in these patients
Correlate clinical histological and biological prognostic factors with outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center disease stage pT3 vs pT4 pathological differentiation poorly or undifferentiated vs well or moderately differentiated and microsatellite instability positive vs negative vs unknown Patients are randomized to 1 of 2 treatment arms
Arm I Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens
Regimen A Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 15 and 29 Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Regimen B Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1 8 15 22 29 and 36 Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Regimen C Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1 8 15 22 29 and 36 Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation only Patients are followed every 6 months
PROJECTED ACCRUAL A total of 1976 patients 988 per treatment arm 247 each in regimens A and B of arm I and 494 in regimen C of arm I will be accrued for this study within 45 years
Primary
Compare 5-year disease-free survival in patients with resected stage II adenocarcinoma of the colon treated with adjuvant chemotherapy comprising fluorouracil and irinotecan with or without leucovorin calcium vs no adjuvant therapy
Secondary
Compare 8-year overall survival in patients treated with these regimens
Compare tolerability of these regimens in these patients
Correlate clinical histological and biological prognostic factors with outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center disease stage pT3 vs pT4 pathological differentiation poorly or undifferentiated vs well or moderately differentiated and microsatellite instability positive vs negative vs unknown Patients are randomized to 1 of 2 treatment arms
Arm I Patients are further randomized to receive 1 of 3 adjuvant chemotherapy regimens
Regimen A Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46 hours on days 1 15 and 29 Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Regimen B Patients receive irinotecan IV over 30-90 minutes followed by leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 24 hours on days 1 8 15 22 29 and 36 Treatment repeats every 56 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Regimen C Patients receive irinotecan IV over 60 minutes followed by fluorouracil IV continuously over 48 hours on days 1 8 15 22 29 and 36 Treatment repeats every 42 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo observation only Patients are followed every 6 months
PROJECTED ACCRUAL A total of 1976 patients 988 per treatment arm 247 each in regimens A and B of arm I and 494 in regimen C of arm I will be accrued for this study within 45 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 |
|---|---|---|---|
| PETACC-4 | None | None | None |
| FFCD-EORTC-40012 | None | None | None |
| EORTC-40012 | None | None | None |