Clinical trial NCT00104676
Conditions: Extragonadal Germ Cell Tumor Teratoma Testicular Germ Cell Tumor
Keywords: stage II malignant testicular germ cell tumor stage III malignant testicular germ cell tumor testicular choriocarcinoma and embryonal carcinoma testicular choriocarcinoma and teratoma testicular choriocarcinoma and yolk sac tumor testicular choriocarcinoma testicular embryonal carcinoma and teratoma testicular embryonal carcinoma and yolk sac tumor testicular embryonal carcinoma testicular yolk sac tumor and teratoma testicular yolk sac tumor stage II extragonadal non-seminomatous germ cell tumor stage III extragonadal non-seminomatous germ cell tumor testicular immature teratoma testicular mature teratoma adult teratoma
Sponsor: UNICANCER
Start date: 2003-11-26; Completion date: 2023-02-08
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). arm 2: 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.
Interventions: intervention 1: bleomycin sulfate intervention 2: cisplatin intervention 3: etoposide intervention 4: ifosfamide intervention 5: oxaliplatin intervention 6: paclitaxel
Intervention descriptions: intervention 1: At least one course administered intervention 2: At least one course administered intervention 3: At least one course administered intervention 4: Given in a dose-dense sequential fashion intervention 5: Given in a dose-dense sequential fashion intervention 6: Given in a dose-dense sequential fashion

Protocol documents: