A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors
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.
OBJECTIVES:
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.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria:
Clinical stage II-III disease (disseminated disease)
Testicular, retroperitoneal, or mediastinal primary site
Poor prognosis disease, meeting 1 of the following criteria:
Mediastinal primary site
Non-pulmonary visceral metastases
One of the following lab values:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery