Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors
- Conditions
- TeratomaExtragonadal Germ Cell TumorTesticular Germ Cell Tumor
- Interventions
- Biological: bleomycin sulfateDrug: cisplatinDrug: etoposideDrug: ifosfamideDrug: oxaliplatinDrug: paclitaxel
- Registration Number
- NCT00104676
- Lead Sponsor
- UNICANCER
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 263
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I bleomycin sulfate Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). Arm II bleomycin sulfate Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. Arm I etoposide Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). Arm I cisplatin Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). Arm II cisplatin Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. Arm II etoposide Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. Arm II ifosfamide Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. Arm II oxaliplatin Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. Arm II paclitaxel Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.
- Primary Outcome Measures
Name Time Method Progression-free Survival Rate After 1 Course of Treatment 3 years from randomization Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.
- Secondary Outcome Measures
Name Time Method Overall Survival 3 years from randomization To evaluated the overall survival in both groups in participants presenting fast and slow decrease in serum levels of tumor markers. The median overall survival was defined as the median percentage of participants alive after 1 course of treatment.
Trial Locations
- Locations (24)
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Centre Henri Becquerel
🇫🇷Rouen, France
National Cancer Institute - Bratislava
🇸🇰Bratislava, Slovakia
Centre Paul Papin
🇫🇷Angers, France
Centre Leon Berard
🇫🇷Lyon, France
Institut Bergonie
🇫🇷Bordeaux, France
C.H.U. de Brest
🇫🇷Brest, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Oscar Lambret
🇫🇷Lille, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Institut Jean Godinot
🇫🇷Reims, France
Hopital Tenon
🇫🇷Paris, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Centre Hospitalier de Rodez
🇫🇷Rodez, France
CRLCC Nantes - Atlantique
🇫🇷Saint-Herblain, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Institut Gustave Roussy
🇫🇷Villejuif, France