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

Information source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Testicular Neoplasms; Germ Cell Tumors

Intervention: Cyclophosphamide (Drug); Etoposide (Drug); Cisplatin (Drug); Bleomycin (Drug); Carboplatin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Official(s) and/or principal investigator(s):
Andrea Necchi, MD, Principal Investigator, Affiliation: Istituto Nazionale dei Tumori, Milano Italy


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.

Clinical Details

Official title: Randomized Phase 2 Study of Conventional Dose Chemotherapy Versus High Dose Sequential Chemotherapy as First-line Therapy for Metastatic Poor Prognosis Germ Cell Tumors

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evidence of disease progression confirmed by computed tomography (CT) scan and/or serum tumor markers.

Secondary outcome: Overall survival


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Male.


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


- Any psychiatric disorder that could impact on the study compliance

Locations and Contacts

Istituto Nazionale dei Tumori, Milano 20133, Italy
Additional Information

Website of the Urology Unit, Istituto Nazionale dei Tumori, Milano Italy

Related publications:

Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Fléchon A, Margolin K, Lotz JP, Germà-Lluch JR, Powles T, Kollmannsberger C, Beyer J. Conventional-dose versus high-dose chemotherapy as first salvage treatment in male patients with metastatic germ cell tumors: evidence from a large international database. J Clin Oncol. 2011 Jun 1;29(16):2178-84. doi: 10.1200/JCO.2010.32.6678. Epub 2011 Mar 28.

Starting date: December 1996
Last updated: June 11, 2014

Page last updated: August 20, 2015

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