Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors

Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors

The purpose of this study is to determine whether the use of a sequential high dose chemotherapy is more effective than conventional dose (i.e. 4 cycles of cisplatin, etoposide, and bleomycin [PEB]) in patients with metastatic poor prognosis germ cell tumors.

Inclusion Criteria:

• Clinical or Histological diagnosis of germ cell tumors
• Metastatic disease
• Poor prognostic category according to the International Germ Cell Collaborative Group (IGCCCG) classification
• No prior chemotherapy for metastatic disease

Exclusion Criteria:

• Unwillingness to accomplish the study procedures
• Any existing co-morbidity that could limit the administration of high dose chemotherapy
• Any psychiatric disorder that could impact on the study compliance