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Clinical trialNCT02375204Active, not recruitingPhase 3Interventional

Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors

SponsorAlliance for Clinical Trials in OncologyEnrollment420Childhood TeratomaChoriocarcinomaExtragonadal SeminomaGerm Cell TumorGerminomaMalignant Germ Cell Neoplasm+5 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

125 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

  • Box Hill Hospital

    Box Hill, Victoria, Australia

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, Australia

Belgium
  • Institut Jules Bordet

    Anderlecht, Belgium

  • University Hospital Saint Luc

    Brussels, Belgium

Denmark
  • Rigshospitalet University Hospital

    Copenhagen, Denmark

France
  • Centre Leon Berard

    Lyon, France

  • Institut Paoli Calmettes

    Marseille, France

  • Hopital Tenon/assistance Publique - Hopitaux de Paris

    Paris, France

  • Chru Strasbourg - Hospital Civil

    Strasbourg, France

  • Center Claudius Regaud

    Toulouse, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, France

  • Gustave Roussy

    Villejuif, France

Germany
  • Technical University Dresden

    Dresden, Saxony, Germany

  • University of Berlin Charite Campus Benjamin Franklin

    Berlin, Germany

  • University of Dusseldorf

    Düsseldorf, Germany

  • University of Essen

    Essen, Germany

  • University Medical Center Hamburg-Eppendorf

    Hamburg, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, Germany

  • Gk-Mittelrhein Saint Martin'S

    Koblenz, Germany

  • Philipps University Marburg

    Marburg, Germany

  • Rotkreuzklinikum Munchen

    Munich, Germany

  • Klinikum Nurnberg Nord

    Nuremberg, Germany

  • University Hospital Ulm

    Ulm, Germany

Ireland
  • Saint James Hospital

    Dublin, Ireland

Italy
  • Ospedale Di Circolo Di Busto Arsizio

    Busto Arsizio, Italy

  • Istituto Scientifico Romagnolo

    Meldola, Italy

  • Istituto Nazionale Tumori

    Milan, Italy

  • San Matteo Hospital

    Pavia, Italy

Netherlands
  • the Netherlands Cancer Institute

    Amsterdam, Netherlands

  • University Medical Center Groningen

    Groningen, Netherlands

  • Radboud University Nijmegen Medical Centre

    Nijmegen, Netherlands

Spain
  • Duran I Reynals Hospital-Catalan Institute of Oncology

    Barcelona, Spain

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital General Universitario Morales Meseguer

    Murcia, Spain

Switzerland
  • Inselspital

    Bern, Switzerland

  • Hopitaux Universitaires de Geneve

    Geneva, Switzerland

  • University Hospital Zurich

    Zurich, Switzerland

85 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Aug 2015
Primary completion
1 Jun 2031
Completion
1 Jun 2031
Last update posted
16 Jun 2026
Registered enrollment
420
Registry id
NCT02375204

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.