Overview

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

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Treatments:
Bleomycin
Carboplatin
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Criteria
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