Prospective Trial for the Diagnosis and Treatment of Intracranial Germ Cell Tumors
Status:
Unknown status
Trial end date:
2018-10-01
Target enrollment:
Participant gender:
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,
Ifosfamide and Etoposide (as approved by German competent authority).
PRIMARY OBJECTIVES:
Germinoma
- To maintain current high event-free survival (EFS) rates using a risk adapted approach
- In localised germinoma: to omit whole brain and spinal irradiation by using combined
treatment with standard chemotherapy and ventricular irradiation (+/- boosts)
- In bifocal tumours (pineal + suprasellar): to treat as non-metastatic disease and to
omit whole brain and spinal irradiation by using combined treatment with standard
chemotherapy and ventricular irradiation (+/- boosts)
- In metastatic disease: to maintain current excellent EFS in metastatic germinoma with
craniospinal irradiation Malignant non-germinoma
To improve EFS:
- by dose escalation of chemotherapy in patients identified as high risk at diagnosis (
age < 6 years and/or AFP serum / CSF > 1000 ng/ml)
- by standardising the surgical approach for residual disease after treatment Teratoma
- To register patients and collect data regarding diagnostics, treatment and outcome in
order to develop future treatment strategies
SECONDARY OBJECTIVES:
Germinoma
- To minimise long term effects of irradiation by sparing spinal and whole brain
radiotherapy in non-metastatic disease Malignant non-germinoma
- In standard risk to maintain EFS with chemotherapy and local irradiation Teratoma
- To evaluate the influence of surgery and treatment on outcome to assist in the
development of a fu-ture treatment strategy For all histological subtypes
- To improve accuracy of diagnosis and staging in all registered patients
- To standardise neurosurgical intervention
- For all patients requiring biopsy or resection according to protocol guidelines, to
collect and to store tumour material, and CSF where possible, for use in future
biological studies.
ENDPOINTS / Criteria for evaluation:
Main end point
Event-free survival, defined as minimum time from the date of diagnosis to:
- Death from any cause
- Relapse
- Progressive disease on therapy
- Or second malignancy
Secondary end points
- Overall survival, defined as time to death from any cause, measured from the date of
diagnosis
- Short and long term toxicity.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital Muenster
Collaborators:
Deutsche Kinderkrebsstiftung Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany Hannover Medical School