Prospective Trial for the Diagnosis and Treatment of Intracranial Germ Cell Tumors

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborators: Deutsche Kinderkrebsstiftung; Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany; Hannover Medical School
• Treatments: Carboplatin; Cisplatin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard

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

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