Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplati
- Conditions
- C80Malignant neoplasm, without specification of site
- Registration Number
- DRKS00019921
- Lead Sponsor
- Medizinische Fakultät der Universität Bonn Rheinische Friedrich-Wilhelms Universität Bonn
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 360
• 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
• Written informed consent prior to trial entry of parents and/or patient
• Diagnosis of a chemotherapy-naïve extracranial MGCT
• Karnofsky-Index of >70% or ECOG-Status 0-II
• Negative pregnancy test within 7 days prior to start of treatment for female patients of childbearing potential, in case of ß-HCG secreting MGCT pregnancy has to be excluded by appropriate methods
Exclusion criteria in general:
• 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 <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.
• Any other medical, psychiatric or drug related condition, or social condition incompatible with protocol treatment.
Note: Patients excluded from the trial based on the presence of exclusion criteria may be eligible for registration as follow-up patients. They shall receive adequate treatment and will not be evaluated for primary and secondary objectives.
Exclusion criteria in special indication:
• Second malignancies
• Negative preoperative tumour markers AFP and ß-HCG and solely pure teratoma histology
• Known hypersensitivity against Cisplatin, Carboplatin, Etoposide, Ifosfamide or other ingredients of the medicinal product
• Hearing impairment Grade 3 and 4 (CTCAE Vers.4.03)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br><br>Event-free survival, defined as minimum time from the date of randomization to the following events (EFSr):<br>• Death from any cause<br>• Progressive disease, defined as increase of standard tumour marker with or without expansion of tumour mass/metastases<br>• Viable tumour cells at time of final surgery<br>• Relapse<br>• Second malignancy<br>• or the date of the last follow-up
- Secondary Outcome Measures
Name Time Method