Status:
UNKNOWN
Prospective Trial for the Diagnosis and Treatment of Intracranial Germ Cell Tumors
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Deutsche Kinderkrebsstiftung
Hannover Medical School
Conditions:
Intracranial Germ Cell Tumors
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
STUDY DESIGN: Prospective, non-randomised multicentre study with patients stratified according to risk groups INVESTIGATIONAL MEDICINAL PRODUCTS The IMPs on this trial are Carboplatin, Cisplatin, Ifo...
Detailed Description
PATIENT POPULATION Age of patients: no lower or upper age limit; Estimated number: 400 malignant germ cell tumours Diagnosis and main criteria for inclusion/exclusion: Intracranial Germ Cell tumours...
Eligibility Criteria
Inclusion
- Main residence in one of the participating countries
- Primary diagnosis of an intracranial germ cell tumour
- Written consent for trial participation, treatment according to the protocol and consent for data transfer
Exclusion
- Tumour entity other than primary intracranial germ cell tumour or CNS GCT as second malignancy
- Primary diagnosis pre-dating the opening of SIOP CNS GCT II in the participating country of registration
- Medical, psychiatric or social conditions incompatible with trial treatment or treatment according to protocol is not intended
- Participation within a different trial for treatment of germ cell tumours and/or concurrent treatment within any other clinical trial. The only exceptions to this are trials with different endpoints, involving aspects of supportive treatment which can run parallel to SIOP CNS GCT II without influencing the outcome of this trial e.g. trials on antiemetics, antimycotics, antibiotics, strategies for psychosocial support etc.
- Pregnancy and lactation
- Any treatment not given according to protocol prior to registration
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01424839
Start Date
October 1 2011
End Date
October 1 2018
Last Update
June 4 2015
Active Locations (1)
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1
University Hospital Muenster
Münster, Germany, 48129