Germ Cell Tumors, Testicular Neoplasms
Conditions
Brief 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.
Interventions
DRUGCyclophosphamide
DRUGEtoposide
DRUGCisplatin
DRUGBleomycin
DRUGCarboplatin
High dose carboplatin
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 5 years |
Countries
Italy
Outcome results
None listed