Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104676
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2005-03-03
Brief Title:
Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
PURPOSE This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors
PURPOSE This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors
Detailed Description:
OBJECTIVES
Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin etoposide and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin etoposide and cisplatin OR dose-dense sequential combination chemotherapy
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study
Patients receive 1 course of bleomycin etoposide and cisplatin BEP Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms
Arm I Patients receive 3 additional courses of BEP
Arm II Patients receive dose-dense sequential combination chemotherapy comprising cisplatin etoposide bleomycin paclitaxel oxaliplatin and ifosfamide
PROJECTED ACCRUAL A total of 260 patients will be accrued for this study
Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment with 1 course of bleomycin etoposide and cisplatin followed by subsequent treatment with 3 additional courses of bleomycin etoposide and cisplatin OR dose-dense sequential combination chemotherapy
Compare overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study
Patients receive 1 course of bleomycin etoposide and cisplatin BEP Patients with a favorable decrease of tumor markers after 1 course of BEP receive 3 additional courses of BEP Patients with an unfavorable decrease of tumor markers after 1 course of BEP are randomized to 1 of 2 treatment arms
Arm I Patients receive 3 additional courses of BEP
Arm II Patients receive dose-dense sequential combination chemotherapy comprising cisplatin etoposide bleomycin paclitaxel oxaliplatin and ifosfamide
PROJECTED ACCRUAL A total of 260 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-001072-13 | EUDRACT_NUMBER | UNICANCER | None |
| FRE-FNCLCC-GETUG-130206 | OTHER | None | None |