Study:
RANDOMIZED MULTIINSTITUTIONAL PHASE III TRIAL OF BEP AND HIGH DOSE CHEMOTHERAPY VERSUS BEP ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH POOR RISK GERM CELL TUMORS
Rationale:
Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not known whether combining chemotherapy with bone marrow
or peripheral stem cell transplantation is more effective than combination chemotherapy
alone in treating men with germ cell tumors.
Purpose:
Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without bone marrow or peripheral stem cell transplantation in treating men with
previously untreated germ cell tumors.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Testicular Germ Cell Tumor |
Biological: bleomycin sulfate
Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy |
Phase 3 |
Verified by
Memorial Sloan-Kettering Cancer Center
October, 2003
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00002596
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195-9001
United States
Robert J. Motzer, MD., Study Chair
Patrick J. Loehrer, MD., Study Chair
Kim A. Margolin, MD., Study Chair
Eric J. Small, MD., Study Chair