Comparison of Carboplatin and Cisplatin in patients with extracranial malignant germ cell tumours

Prior treatment

• 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.

Other illness

• 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

Other

• Pregnancy
• Lactation
• Incomplete data at trial entry preventing risk group allocation
• Actual audiometry not available ( does not apply to low risk patients)

• 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