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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase

Completed

Phase 2

Conditions

Germ Cell Tumors

Testicular Neoplasms

Treatments

Drug: Bleomycin

Drug: Cyclophosphamide

Drug: Cisplatin

Drug: Carboplatin

Drug: Etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT02161692

INT48/96

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

High dose chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Etoposide

Drug: Carboplatin

Drug: Cyclophosphamide

Drug: Cisplatin

Conventional dose chemotherapy

Active Comparator group

Description:

Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles

Treatment:

Drug: Etoposide

Drug: Cisplatin