Diagnosis and treatment of unusual brain tumours in childre

Phase 1

• Conditions: Intracranial germ cell tumours of any histology and intracranial site and dissemination; MedDRA version: 16.1Level: LLTClassification code 10065853Term: Nongerminomatous germ cell tumor of the CNSSystem Organ Class: 100000004864; MedDRA version: 16.1Level: LLTClassification code 10018207Term: GerminomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-018072-33-SE
• Lead Sponsor: niversitätsklinikum Münster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-02
• Study Completion: 2020-06-30
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

•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

Are the trial subjects under 18? yes
Number of subjects for this age range: 348
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•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 registra-tion
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified