NCT02161692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1996

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1996

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
Last Updated

June 12, 2014

Status Verified

June 1, 2014

Enrollment Period

10.4 years

First QC Date

June 10, 2014

Last Update Submit

June 11, 2014

Conditions

Testicular NeoplasmsGerm Cell Tumors

Outcome Measures

Primary Outcomes (1)

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

    5 years

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

High dose chemotherapy

EXPERIMENTAL

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: CyclophosphamideDrug: EtoposideDrug: CisplatinDrug: Carboplatin

Conventional dose chemotherapy

ACTIVE COMPARATOR

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

Drug: EtoposideDrug: CisplatinDrug: Bleomycin

Interventions

CyclophosphamideDRUG
High dose chemotherapy
EtoposideDRUG
Conventional dose chemotherapyHigh dose chemotherapy
CisplatinDRUG
Conventional dose chemotherapyHigh dose chemotherapy
BleomycinDRUG
Conventional dose chemotherapy
CarboplatinDRUG

High dose carboplatin

High dose chemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Nazionale dei Tumori

Milan, Milano, 20133, Italy

Location

Related Publications (2)

  • 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.

    PMID: 21444870BACKGROUND

  • 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.

    PMID: 25344361DERIVED

MeSH Terms

Conditions

Testicular NeoplasmsNeoplasms, Germ Cell and Embryonal

Interventions

CyclophosphamideEtoposideCisplatinBleomycinCarboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal DisordersNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and ProteinsCoordination Complexes

Study Officials

  • Andrea Necchi, MD

    Istituto Nazionale dei Tumori, Milano Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty, Department of Medical Oncology

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

December 1, 1996

Primary Completion

May 1, 2007

Study Completion

April 1, 2009

Last Updated

June 12, 2014

Record last verified: 2014-06

Locations

IT(1)