Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004150
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-12-10
Brief Title:
High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer
Sponsor:
Robert Roessle Klinik
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Pan-European Trials in Adjuvant Colon Cancer PETACC-2 Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU or - Folinic Acid Versus Standard Bolus 5-FUFolinic Acid
Status:
COMPLETED
Status Verified Date:
2001-02
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 use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which chemotherapy regimen is more effective for colon cancer
PURPOSE This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer
PURPOSE This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer
Detailed Description:
OBJECTIVES
Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection
Compare the safety of these regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to regional lymph node involvement N1 1-3 pericolic lymph nodes vs N2 more than 3 pericolic lymph nodes and participating center
Patients are randomized to one of two treatment arms
Arm I Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5 Treatment repeats every 4 weeks for 6 courses
Arm II Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks Treatment repeats every 8 weeks for 3 courses
OR
Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks Treatment repeats every 7 weeks for 3 courses
OR
Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2 Treatment repeats every 2 weeks for 12 courses
Patients are followed at 1 month every 6 months for 45 years and then annually thereafter until death
PROJECTED ACCRUAL Approximately 1600 patients 800 per treatment arm will be accrued for this study within 3 years
Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection
Compare the safety of these regimens in this patient population
OUTLINE This is a randomized multicenter study Patients are stratified according to regional lymph node involvement N1 1-3 pericolic lymph nodes vs N2 more than 3 pericolic lymph nodes and participating center
Patients are randomized to one of two treatment arms
Arm I Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5 Treatment repeats every 4 weeks for 6 courses
Arm II Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks Treatment repeats every 8 weeks for 3 courses
OR
Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks Treatment repeats every 7 weeks for 3 courses
OR
Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2 Treatment repeats every 2 weeks for 12 courses
Patients are followed at 1 month every 6 months for 45 years and then annually thereafter until death
PROJECTED ACCRUAL Approximately 1600 patients 800 per treatment arm will be accrued for this study within 3 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 |
|---|---|---|---|
| GETTD-PETACC-2 | None | None | None |
| EORTC-40963 | None | None | None |
| FFCD-PETACC-2 | None | None | None |
| PETACC-2 | None | None | None |