Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046995
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2002-10-03
Brief Title:
Combination Chemotherapy in Treating Patients With Colon Cancer
Sponsor:
Groupe Regional dEtudes du Cancer Colorectal
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
5-Fluorouracil-Leucovorin With or Without Carboplatin as Adjuvant Treatment for Primary Dukes B2-C Colon Cancer Chronomodulated Versus Standard Administration A Multicenter Randomized Phase III Trial of the GRECCR-Belgium Study 03
Status:
UNKNOWN
Status Verified Date:
2002-11
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 use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known which schedule of chemotherapy is most effective in treating colon cancer
PURPOSE Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer
PURPOSE Randomized phase III trial to compare different schedules of chemotherapy using carboplatin with fluorouracil and leucovorin in treating patients who have stage IIB or stage III colon cancer
Detailed Description:
OBJECTIVES
Compare the disease-free survival of patients with completely resected stage IIB or III colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil and leucovorin calcium with or without carboplatin
Compare the overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Determine the dose intensities of fluorouracil and carboplatin in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and disease stage IIB vs III Patients are randomized to 1 of 4 treatment arms
Arm I standard schedule Patients receive fluorouracil 5-FU IV continuously and leucovorin calcium CF IV on days 1 and 2
Arm II standard carboplatin schedule Patients receive 5-FU and CF as in arm I plus carboplatin IV on day 1
Arm III chronomodulated schedule Patients receive 5-FU IV continuously and CF IV continuously on days 1-4
Arm IV chronomodulated carboplatin schedule Patients receive 5-FU and CF as in arm III plus carboplatin IV continuously on days 1-4
Quality of life is assessed
Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 660-800 patients will be accrued for this study
Compare the disease-free survival of patients with completely resected stage IIB or III colon cancer treated with adjuvant chronomodulated vs standard schedule fluorouracil and leucovorin calcium with or without carboplatin
Compare the overall survival of patients treated with these regimens
Compare the toxicity of these regimens in these patients
Compare the quality of life of patients treated with these regimens
Determine the dose intensities of fluorouracil and carboplatin in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center and disease stage IIB vs III Patients are randomized to 1 of 4 treatment arms
Arm I standard schedule Patients receive fluorouracil 5-FU IV continuously and leucovorin calcium CF IV on days 1 and 2
Arm II standard carboplatin schedule Patients receive 5-FU and CF as in arm I plus carboplatin IV on day 1
Arm III chronomodulated schedule Patients receive 5-FU IV continuously and CF IV continuously on days 1-4
Arm IV chronomodulated carboplatin schedule Patients receive 5-FU and CF as in arm III plus carboplatin IV continuously on days 1-4
Quality of life is assessed
Treatment in all arms repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 660-800 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20201 | None | None | None |
| GRECCR-03 | None | None | None |