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

Phase 2

Completed

• Conditions: Testicular Neoplasms; Germ Cell Tumors
• Interventions: Drug: Cyclophosphamide; Drug: Cisplatin; Drug: Etoposide; Drug: Bleomycin; Drug: Carboplatin

• Registration Number: NCT02161692
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1996-12
• Primary Completion: 2007-05
• Study Completion: 2009-04
• Status Verified: 2014-06
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Last Update Submitted: 2014-06-11
• Study First Posted: 2014-06-12
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional dose chemotherapy	Cisplatin	Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
High dose chemotherapy	Carboplatin	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
High dose chemotherapy	Cyclophosphamide	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
High dose chemotherapy	Etoposide	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
High dose chemotherapy	Cisplatin	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
Conventional dose chemotherapy	Etoposide	Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Conventional dose chemotherapy	Bleomycin	Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles

Primary Outcome Measures

Name	Time	Method
Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years

Trial Locations

Locations (1)

Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy