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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Testicular Neoplasms Germ Cell Tumors

Interventions

CyclophosphamideDRUG

EtoposideDRUG

CisplatinDRUG

BleomycinDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Nazionale dei Tumori

Milan, Milano, Italy

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

Time frame: 5 years

Data from ClinicalTrials.gov

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