Comparison of Carboplatin and Cisplatin in patients with extracranial malignant germ cell tumours
Key facts
- Where
- Aachen, Augsburg, Berlin, Bielefeld, Bonn, Bremen, Brunswick, Cologne, Cottbus, Datteln, Dortmund, Dresden, Duesseldorf, Erfurt, Erlangen, Essen, Frankfurt am Main, Freiburg im Breisgau, Giessen, Goettingen, Greifswald, Halle, Hamburg, Hanover, Heidelberg, Heilbronn, Herdecke, Homburg, Jena, Karlsruhe, Kassel, Kiel, Koblenz, Krefeld, Leipzig, Lübeck, Magdeburg, Mainz, Mannheim, Minden, Muenster, Munich, Nürnberg, Oldenburg, Regensburg, Rostock, Sankt Augustin, Schwerin, Stuttgart, Tuebingen, Ulm és Wuerzburg, NémetországSee the 58 sites
- Phase
- 3. fázis
Where in Németország
- Universitaetsklinikum Aachen AöRAachen, NémetországNo longer taking part
- Universitaetsklinikum AugsburgAugsburg, NémetországNo longer taking part
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországNo longer taking part
- HELIOS Klinikum Berlin Buch GmbHBerlin, NémetországNo longer taking part
- Evangelisches Klinikum Bethel gGmbHBielefeld, NémetországNo longer taking part
- Rheinische Friedrich-Wilhelms-Universitaet BonnBonn, NémetországNo longer taking part
- Gesundheit Nord gGmbH Klinikverbund BremenBremen, NémetországNo longer taking part
- Staedtisches Klinikum Braunschweig gGmbHBrunswick, NémetországNo longer taking part
- Kliniken der Stadt Koeln gGmbHCologne, NémetországNo longer taking part
- Universitaetsklinikum Koeln AöRCologne, NémetországNo longer taking part
- Medical University Of Lausitz Carl ThiemCottbus, NémetországNo longer taking part
- Vestische Kinder- und Jugendklinik DattelnDatteln, NémetországNo longer taking part
- Klinikum Dortmund gGmbHDortmund, NémetországNo longer taking part
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, NémetországNo longer taking part
- Kaiserswerther DiakonieDuesseldorf, NémetországNo longer taking part
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, NémetországNo longer taking part
- HELIOS Klinikum Erfurt GmbHErfurt, NémetországNo longer taking part
- Universitaetsklinikum Erlangen AöRErlangen, NémetországNo longer taking part
- Universitaetsklinikum Essen (AoR)Essen, NémetországNo longer taking part
- Universitätsklinikum FrankfurtFrankfurt am Main, NémetországNo longer taking part
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországNo longer taking part
- Justus-Liebig-Universitaet GiessenGiessen, NémetországNo longer taking part
- Universitaetsmedizin GoettingenGoettingen, NémetországNo longer taking part
- Universitätsmedizin GreifswaldGreifswald, NémetországNo longer taking part
- Universtitätsklinikum Halle (Saale) AöRHalle, NémetországNo longer taking part
- University Medical Center Hamburg-EppendorfHamburg, NémetországNo longer taking part
- Medizinische Hochschule HannoverHanover, NémetországNo longer taking part
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországNo longer taking part
- SLK-Kliniken Heilbronn GmbHHeilbronn, NémetországNo longer taking part
- Gemeinschaftskrankenhaus Herdecke gGmbHHerdecke, NémetországNo longer taking part
- Saarland University HospitalHomburg, NémetországNo longer taking part
- University Hospital Jena KöRJena, NémetországNo longer taking part
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, NémetországNo longer taking part
- Klinikum Kassel GmbHKassel, NémetországNo longer taking part
- Universitaetsklinikum Schleswig-HolsteinKiel, NémetországNo longer taking part
- Childrens Hospital Of KoblenzKoblenz, NémetországNo longer taking part
- HELIOS Klinikum Krefeld GmbHKrefeld, NémetországNo longer taking part
- Universitaet LeipzigLeipzig, NémetországNo longer taking part
- University of LuebeckLübeck, NémetországNo longer taking part
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországNo longer taking part
- Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University MainzMainz, NémetországNo longer taking part
- Universitaetsklinikum Mannheim GmbHMannheim, NémetországNo longer taking part
- Johannes Wesling Klinikum MindenMinden, NémetországNo longer taking part
- Universitaetsklinikum Muenster AöRMuenster, NémetországNo longer taking part
- Hospital Munich SchwabingMunich, NémetországNo longer taking part
- Klinikum der Universitaet Muenchen AöRMunich, NémetországNo longer taking part
- Ludwig Maximilian University Of MunichMunich, NémetországNo longer taking part
- Technical University Of Munich School Of MedicineMunich, NémetországNo longer taking part
- Diakoneo Klinik Hallerwiese-Cnopfsche KinderklinikNürnberg, NémetországNo longer taking part
- Klinikum Oldenburg AorOldenburg, NémetországNo longer taking part
- Universitaetsklinikum Regensburg AöRRegensburg, NémetországNo longer taking part
- Universitätsmedizin RostockRostock, NémetországNo longer taking part
- Asklepios-Klinik, Sankt Augustin GmbHSankt Augustin, NémetországNo longer taking part
- HELIOS Kliniken Schwerin GmbHSchwerin, NémetországNo longer taking part
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, NémetországNo longer taking part
- Universitaetsklinikum Tuebingen AöRTuebingen, NémetországNo longer taking part
- Universitaetsklinikum Ulm AoRUlm, NémetországNo longer taking part
- Universitaetsklinikum Wuerzburg AöRWuerzburg, NémetországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Rheinische Friedrich-Wilhelms-Universitaet Bonn
- Trial code
- EU 2023-507582-25-00
- Record updated
- 2026. július 17.
- Original description
To assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle / AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant germ cell tumours (MGCT) of intermediate, high and very high risk with regard to Event-free-survival (EFSr)Read full original descriptionShow less
Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin (MAKEI V)
To assess in a randomized comparison whether the efficacy of Carboplatin (600 mg/m² per cycle / AUC 7.9 mg/ml/min.) is not inferior to Cisplatin (100 mg/m² per cycle) in malignant germ cell tumours (MGCT) of intermediate, high and very high risk with regard to Event-free-survival (EFSr)
Inclusion: Confirmed extracranial MGCT up to 17 11/12 years of age or patients with ovarian primaries up to 29 11/12 years of age on the date of written informed consent; Diagnosis of a chemotherapy-naïve extracranial MGCT; Written informed consent of patients and/or their parents according to national law prior to trial entry; Karnofsky-Index of >70% or ECOG-Status 0-II; Negative pregnancy test within 7 days prior to starting treatment for female patients of childbearing potential, in case of ß-HCG secreting MGCT pregnancy has to be excluded by appropriate methods.
Exclusion: Live vaccine immunization within two weeks before start of protocol treatment; Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of chemotherapy; Current or recent (within 30 days prior to date of informed written consent) treatment with another investigational drug or participation in another interventional clinical trial, except trials with different end points than MAKEI V that can run in parallel to MAKEI V without influencing that trial, e.g., trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support, etc; HIV-positivity (does not apply to low risk patients, but must be available before randomisation); Any other medical, psychiatric or drug related condition, or social condition incompatible with protocol treatment; Pregnancy; Lactation; Incomplete data at trial entry preventing risk group allocation; Actual audiometry not available ( does not apply to low risk patients).