Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003941
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy With or Without Peripheral Stem Cell Transplant in Treating Men With Previously Untreated Germ Cell 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:
A Randomized Phase III Study of Sequential High-Dose CisplatinumEtoposideIfosfamide Plus Stem Cell Support Versus BEP in Patients With Poor Prognosis Germ Cell Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy and kill more cancer cells It is not yet known whether chemotherapy and peripheral stem cell transplant is more effective than chemotherapy alone
PURPOSE This randomized phase III trial is studying how well combination chemotherapy works when given with peripheral stem cell transplant and how it compares with combination chemotherapy alone in treating men with previously untreated germ cell cancer
PURPOSE This randomized phase III trial is studying how well combination chemotherapy works when given with peripheral stem cell transplant and how it compares with combination chemotherapy alone in treating men with previously untreated germ cell cancer
Detailed Description:
OBJECTIVES
Compare the efficacy of standard cisplatin etoposide and ifosfamide VIP followed by sequential high-dose VIP and stem cell rescue versus bleomycin etoposide and cisplatin BEP in men with previously untreated poor-prognosis germ cell cancer
Compare the acute and late toxicities of these treatment regimens in this patient population
Compare these regimens in terms of failure-free survival response rate and overall survival in these patients
Evaluate the quality of life in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center primary mediastinal germ cell tumor yes vs no and nonpulmonary visceral metastases liver vs bone vs brain Patients are randomized to one of two treatment arms
Arm I Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour on days 1-5 and bleomycin IV over 30 minutes on days 2 8 and 15 Treatment repeats every 3 weeks for 4 courses
Arm II Patients receive 1 course of standard dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 Peripheral blood stem cells PBSC are harvested around day 12-15 Patients also receive daily filgrastim G-CSF subcutaneously beginning on day 6 and continuing until PBSC collection is complete
After day 21 patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days -6 through -2 PBSCs are infused on day 0 Patients receive daily G-CSF subcutaneously beginning on day 1 and continuing through day 19 or until blood counts have recovered Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before chemotherapy at 6 months and at 2 years after treatment
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year every 6 months for 1 year and annually thereafter
PROJECTED ACCRUAL A total of 222 patients 111 per treatment arm will be accrued for this study within 2 years
Compare the efficacy of standard cisplatin etoposide and ifosfamide VIP followed by sequential high-dose VIP and stem cell rescue versus bleomycin etoposide and cisplatin BEP in men with previously untreated poor-prognosis germ cell cancer
Compare the acute and late toxicities of these treatment regimens in this patient population
Compare these regimens in terms of failure-free survival response rate and overall survival in these patients
Evaluate the quality of life in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center primary mediastinal germ cell tumor yes vs no and nonpulmonary visceral metastases liver vs bone vs brain Patients are randomized to one of two treatment arms
Arm I Patients receive etoposide IV over 1 hour followed by cisplatin IV over 1 hour on days 1-5 and bleomycin IV over 30 minutes on days 2 8 and 15 Treatment repeats every 3 weeks for 4 courses
Arm II Patients receive 1 course of standard dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days 1-5 Peripheral blood stem cells PBSC are harvested around day 12-15 Patients also receive daily filgrastim G-CSF subcutaneously beginning on day 6 and continuing until PBSC collection is complete
After day 21 patients receive high-dose chemotherapy consisting of etoposide IV over 1 hour followed by cisplatin IV over 1 hour and ifosfamide IV over 1 hour on days -6 through -2 PBSCs are infused on day 0 Patients receive daily G-CSF subcutaneously beginning on day 1 and continuing through day 19 or until blood counts have recovered Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed before chemotherapy at 6 months and at 2 years after treatment
Patients are followed monthly for 1 year every 2 months for 1 year every 3 months for 1 year every 6 months for 1 year and annually thereafter
PROJECTED ACCRUAL A total of 222 patients 111 per treatment arm will be accrued for this study within 2 years
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 |
|---|---|---|---|
| EORTC-30974 | None | None | None |