Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors
Overview
- Phase
- Phase 2
- Intervention
- Bleomycin
- Conditions
- Testicular Neoplasms
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Locations
- 1
- Primary Endpoint
- Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Andrea Necchi
Faculty, Department of Medical Oncology
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Eligibility 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
Arms & Interventions
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Intervention: Bleomycin
High dose chemotherapy
Characterized by the following sequence: High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin 1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
Intervention: Cyclophosphamide
High dose chemotherapy
Characterized by the following sequence: High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin 1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
Intervention: Etoposide
High dose chemotherapy
Characterized by the following sequence: High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin 1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
Intervention: Cisplatin
High dose chemotherapy
Characterized by the following sequence: High dose cyclophosphamide (7 grams/squared meter) x 1 cycle 2 cycles of high-dose etoposide and cisplatin 1 cycle of high dose carboplatin (Area Under the Curve 27) with stem cell rescue
Intervention: Carboplatin
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Intervention: Etoposide
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Intervention: Cisplatin
Outcomes
Primary Outcomes
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.
Time Frame: 5 years
Secondary Outcomes
- Overall survival(5 years)