Intracranial Germ Cell Tumors Clinical Trial
— SIOPCNSGCTIIOfficial title:
SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors
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.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 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 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Muenster | Muenster |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Muenster | Deutsche Kinderkrebsstiftung, Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany, Hannover Medical School |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | survival | Survival rates in respect to applied treatment , according to Kaplan-Meier estimation , 5 years event free survival | 5 years event free survival | Yes |
| Secondary | short and long term toxicity | toxicity of treatment will be assessed with CTC criteria, severe toxicity will be analysed by safety desk | until 7 years after start of trial | Yes |
| Secondary | overall survival | Overall survival will be measured by Kaplan -Meier Estimation , 5 years overall survival | 7 years after start of trial | Yes |