Clinical Trial: Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Risk-Adapted Strategy of the Use of Dose-Dense Chemotherapy in Patients With Poor-Prognosis Disseminated Non-Seminomatous Germ Cell Tumors

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 Summary:

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.


Sponsor: UNICANCER

Current Primary Outcome:

  • Progression-free survival rate after 1 course of treatment
  • Overall survival


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: March 3, 2005
Date Started: November 2003
Date Completion:
Last Updated: December 13, 2009
Last Verified: November 2008