NCT00104676

Combination Chemotherapy in Treating Patients With Stage II or Stage III 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extragonadal Germ Cell Tumor
• Teratoma
• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
BIOLOGICAL	bleomycin sulfate	At least one course administered
DRUG	cisplatin	At least one course administered
DRUG	etoposide	At least one course administered
DRUG	ifosfamide	Given in a dose-dense sequential fashion
DRUG	oxaliplatin	Given in a dose-dense sequential fashion
DRUG	paclitaxel	Given in a dose-dense sequential fashion

Timeline

• Start date: 2003-11-26
• Primary completion: 2012-03-29
• Completion: 2023-02-08
• First posted: 2005-03-04
• Last updated: 2025-02-06
• Results posted: 2021-06-07

Locations

24 sites across 3 countries: United States, France, Slovakia

Regulatory

• FDA-regulated drug study