A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
- 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.
Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate after 1 course of treatment
Karim Fizazi, MD, PhD
Gustave Roussy, Cancer Campus, Grand Paris
|M. D. Anderson Cancer Center at University of Texas||Houston, Texas 77030-4009|