EUCTR2009-018072-33-SE
Active, not recruiting
Phase 1
Prospective Trial for the diagnosis and treatment of children, adolescents and young adults with intracranial germ cell tumours - SIOP CNS GCT II
niversitätsklinikum Münster0 sites394 target enrollmentFebruary 2, 2012
ConditionsIntracranial germ cell tumours of any histology and intracranial site and disseminationMedDRA version: 16.1Level: LLTClassification code 10065853Term: Nongerminomatous germ cell tumor of the CNSSystem Organ Class: 100000004864MedDRA version: 16.1Level: LLTClassification code 10018207Term: GerminomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Intracranial germ cell tumours of any histology and intracranial site and dissemination
- Sponsor
- niversitätsklinikum Münster
- Enrollment
- 394
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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