CompletedNCT02161692Updated Jun 12, 2014

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

A Phase 2 interventional study of Cyclophosphamide and Etoposide in Testicular Neoplasms and Germ Cell Tumors, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Completed at 1 site in Italy. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-06-12.

Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: Male

Study 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.

Conditions studied

Testicular Neoplasms
Germ Cell Tumors

Browse trials for

In context

Neoplasms, Germ Cell and Embryonal

291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.

Browse Neoplasms, Germ Cell and Embryonal studies →

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 169 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: Male
Accepts healthy volunteers: No

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

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

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)

Study arms

Experimental
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
Drug: Cyclophosphamide · Drug: Etoposide · Drug: Cisplatin · Drug: Carboplatin
Active comparator
Conventional dose chemotherapy
Cisplatin, Etoposide, and Bleomycin (PEB) x 4 cycles
Drug: Etoposide · Drug: Cisplatin · Drug: Bleomycin

Interventions

DrugCyclophosphamide
DrugEtoposide
DrugCisplatin
DrugBleomycin
DrugCarboplatin
High dose carboplatin

What researchers measure

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

Study locations

1 site

Istituto Nazionale dei Tumori
Milano, 20133, Italy

References and documents

Publications

Lorch A, Bascoul-Mollevi C, Kramar A, Einhorn L, Necchi A, Massard C, De Giorgi U, Flechon A, Margolin K, Lotz JP, Germa-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. PubMed 21444870 ↗
Necchi A, Mariani L, Di Nicola M, Lo Vullo S, Nicolai N, Giannatempo P, Raggi D, Fare E, Magni M, Piva L, Matteucci P, Catanzaro M, Biasoni D, Torelli T, Stagni S, Bengala C, Barone C, Schiavetto I, Siena S, Carlo-Stella C, Pizzocaro G, Salvioni R, Gianni AM. High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study. Ann Oncol. 2015 Jan;26(1):167-172. doi: 10.1093/annonc/mdu485. Epub 2014 Oct 24. PubMed 25344361 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02161692
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Responsible party: Andrea Necchi (Faculty, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano) — Principal investigator
First posted: Jun 12, 2014
Start date: Dec 1996
Primary completion: May 2007
Completion: Apr 2009
Last update: Jun 12, 2014

Study contacts

Andrea Necchi, MD

principal investigator · Istituto Nazionale dei Tumori, Milano Italy

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms, Germ Cell and Embryonal→

Other studies from this sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Start the discussion