NL-OMON51290RecruitingPhase 3
Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin - MAKEI-V
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 25
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 to 64 (—)
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
- •- 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
- •- 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
- •- Any other medical, psychiatric or drug related condition, or social condition
- •incompatible with protocol treatment.
Investigators
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