Clinical Trial: Prospective Trial for the Diagnosis and Treatment of Intracranial Germ Cell Tumors
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: SIOP CNS GCT II: Prospective Trial for the Diagnosis and Treatment of Children, Adolescents and Young Adults With Intracranial Germ Cell Tumors
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, 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:
Ge
Detailed Summary:
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 of any histology and intracranial site and dissemination
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 trans-fer
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
Sponsor: University Hospital Muenster
Current Primary Outcome: survival [ Time Frame: 5 years event free survival ]
Survival rates in respect to applied treatment , according to Kaplan-Meier estimation , 5 years event free survival
Original Primary Outcome: Same as current
Current Secondary Outcome:
- short and long term toxicity [ Time Frame: until 7 years after start of trial ]toxicity of treatment will be assessed with CTC criteria, severe toxicity will be analysed by safety desk
- overall survival [ Time Frame: 7 years after start of trial ]Overall survival will be measured by Kaplan -Meier Estimation , 5 years overall survival
Original Secondary Outcome: Same as current
Information By: University Hospital Muenster
Dates:
Date Received: August 11, 2011
Date Started: October 2011
Date Completion: October 2018
Last Updated: June 3, 2015
Last Verified: June 2015
- short and long term toxicity [ Time Frame: until 7 years after start of trial ]