germ cell malignancy Germ cell tumor
Conditions
Interventions
Randomised treatment of participants with intermediate, high, or very high risk
disease with standard cisplatin (100 mg/m2 per cycle) or carboplatin (600 mg/m2
per cycle)
Sponsors
Rheinische Friedrich-Wilhelms Universität Bonn
Eligibility
Age
No minimum to 64 Years
Inclusion criteria
Inclusion criteria: - 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 criteria
Exclusion criteria: - Pregnancy - Lactation - Incomplete data at trial entry preventing risk group allocation - HIV-positivity - Live vaccine immunization within two weeks before start of protocol treatment - Sexually active adolescents not willing to use highly effective contraceptive method (pearl index
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival, defined as minimum time from the date of randomization to the following events (EFSr): - Death from any cause - Progressive disease, defined as increase of standard tumour marker with or without expansion of tumour mass/metastases - Viable tumour cells at time of final surgery - Relapse - Second malignancy - or the date of the last follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| - Event-free survival (EFS), defined as minimum time from the date of diagnosis to any of the events described above or to last follow-up, of all patients included in MAKEI V in respect to the defined MAKEI V risk groups - Overall survival (OS), defined as minimum time from the date of diagnosis to death of any cause or to last follow-up, of all patients included in MAKEI V in respect to the defined MAKEI V risk groups - Health economic parameter, e.g. hospitalization days during treatment, number of blood transfusions, in respect to treatment with Carboplatin or Cisplatin - Short and late toxicities according to CTCAE v4.03 - Assessment of safety: Adverse events and laboratory abnormalitie, CTCAE v4.03 grade, timing, seriousness and relatedness. - Fertility relevant endocrine outcomes, e.g. Estrogen, AMH, LH, FSH, Inhibin B. - Patient reported outcomes including HRQoL, fatigue, sexual function and fertility outcomes (in adult patients) - Determination of risk for relapse in respect to used surgical intervention - Radiological response rate after two (and if applicable four) cycles of either Carboplatin or Cisplatin chemotherapy - Standard tumour marker levels after every cycle of either Carboplatin or Cisplatin chemotherapy | — |
Countries
Netherlands
Outcome results
None listed