Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplati

Phase 3

Recruiting

Conditions: 10027655
germ cell malignancy
Germ cell tumor

Registration Number: NL-OMON51290

Lead Sponsor: Rheinische Friedrich-Wilhelms Universität Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 25

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

- 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Event-free survival, defined as minimum time from the date of randomization to<br /><br>the following events (EFSr):<br /><br>- Death from any cause<br /><br>- Progressive disease, defined as increase of standard tumour marker with or<br /><br>without expansion of tumour mass/metastases<br /><br>- Viable tumour cells at time of final surgery<br /><br>- Relapse<br /><br>- Second malignancy<br /><br>- or the date of the last follow-up</p><br>

Secondary Outcome Measures