MAKEI V (Germ cell tumors) - Prinses Máxima Centrum

Who can enter

Children with a newly diagnosed extracranial germ cell tumor
0-18 years

Goal

The goal of this study is to improve the treatment of children with a newly diagnoses extracranial germ cell tumor.

Background

Some children with germ cell tumors are treated with courses of chemotherapy. One of the most important and widely used drugs in the treatment of germ cell tumors is cisplatin. This drug has been shown to be effective, but is also known to cause side effects and late effects.

Carboplatin has a similar effect and causes fewer side effects in most patients. In this study we want to investigate whether carboplatin is as effective as cisplatin, and whether carboplatin indeed causes fewer side effects.

Study details

Official title
Multicentre prospective trial for extracranial malignant germ cell tumours including a randomized comparison of Carboplatin and Cisplatin.

Cancer type
Extracranial germ cell tumor

Phase
3

Maximum number of patients
360, of whom 25 are expected to participate in the Netherlands.

Start date
August 29, 2023

Status
Open

Local principal investigator
Dr. A.M.C. Mavinkurve-Groothuis

Sponsor
University of Bonn, Germany

Approval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO and Government of the Netherlands.

Trial registry number
EU Clinical Trials Register, EudraCT Number: 2016-001784-36

In order to participate in a study please refer to your/your child’s doctor.

Last reviewed

March 25, 2024