Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002722
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
1999-11-01
Brief Title:
High-Dose Chemotherapy in Treating Patients With Advanced Stomach Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
RANDOMIZED PHASE II STUDY OF A WEEKLY 24H-INFUSION OF HIGH-DOSE 5-FU PLUS OR MINUS FOLINIC ACID HD-FUFA VERSUS HD-FUFA PLUS BIWEEKLY CISPLATIN VERSUS FAMTX 5-FUADRIAMYCINMETHOTREXATE IN ADVANCED GASTRIC CANCER AN EORTCAIO INTERGROUP TRIAL
Status:
COMPLETED
Status Verified Date:
2012-03
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 Combining more than one drug and giving higher doses may kill more tumor cells
PURPOSE Randomized phase II trial to study the effectiveness of high-dose chemotherapy in treating patients with advanced stomach cancer
PURPOSE Randomized phase II trial to study the effectiveness of high-dose chemotherapy in treating patients with advanced stomach cancer
Detailed Description:
OBJECTIVES I Determine the response rates in patients with advanced gastric cancer treated with high-dose fluorouracil 5-FU with vs without high-dose leucovorin CF vs high-dose 5-FUCFcisplatin II Determine the toxic effects of these regimens in these patients III Assess the symptomatic improvement in these patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center WHO performance status 0 or 1 vs 2 and disease stage metastatic vs locally advanced Patients are randomized to 1 of 3 treatment arms Arm I Patients receive fluorouracil 5-FU IV over 24 hours weekly for 6 weeks Arm II Patients receive leucovorin calcium CF IV over 2 hours followed by 5-FU IV over 24 hours weekly for 6 weeks Arm III Patients receive CF and 5-FU as in arm II and cisplatin IV over 1 hour on days 1 15 and 29 Treatment repeats every 7 weeks for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 65-135 patients 21-45 per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center WHO performance status 0 or 1 vs 2 and disease stage metastatic vs locally advanced Patients are randomized to 1 of 3 treatment arms Arm I Patients receive fluorouracil 5-FU IV over 24 hours weekly for 6 weeks Arm II Patients receive leucovorin calcium CF IV over 2 hours followed by 5-FU IV over 24 hours weekly for 6 weeks Arm III Patients receive CF and 5-FU as in arm II and cisplatin IV over 1 hour on days 1 15 and 29 Treatment repeats every 7 weeks for a maximum of 4 courses in the absence of unacceptable toxicity or disease progression Patients are followed every 8 weeks
PROJECTED ACCRUAL A total of 65-135 patients 21-45 per arm 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 |
|---|---|---|---|
| GER-AIO-0295 | None | None | None |
| EORTC-40953 | None | None | None |