Paediatric brain tumours

Prospective Trial for the diagnosis and treatment of children, adolescents and young adults with Intracranial Germ Cell Tumours - SIOP CNS GCT II

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-018072-33-DE

Enrollment

400

Registered

2011-06-06

Start date

2011-08-01

Completion date

Unknown

Last updated

2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Germ Cell tumours of any histology and intracranial site and dissemination MedDRA version: 20.0 Level: LLT Classification code 10065853 Term: Nongerminomatous germ cell tumor of the CNS System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10018207 Term: Germinoma System Organ Class: 100000004864

Interventions

Trade Name: e.g. Cisplatin 1mg/ml Sterile Concentrate Product Name: Cisplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Cisplatin CAS Number: 15663-27-1 Product

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 irra-diation (+/- boosts) -In metastatic disease: to maintain current excellent EFS in metastatic germinoma with craniospinal irradiation Malignant non-germinoma -To improve EFS in high risk patients by intensifying treatment -by dose escalation of chemotherapy in patients identified as high risk at diagnosis -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 Objective: 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 store tumour mate-rial, and CSF where possible, for use in future biological studies;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 2 years following the last patient recruited	—

Measure

Time frame

Main Objective: 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 irra-diation (+/- boosts) -In metastatic disease: to maintain current excellent EFS in metastatic germinoma with craniospinal irradiation Malignant non-germinoma -To improve EFS in high risk patients by intensifying treatment -by dose escalation of chemotherapy in patients identified as high risk at diagnosis -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 Objective: 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 store tumour mate-rial, and CSF where possible, for use in future biological studies;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 2 years following the last patient recruited

—

Secondary

Measure	Time frame
Secondary end point(s): • Overall survival, defined as time to death from any cause, measured from the date of diagnosis • Short and long term toxicity. ;Timepoint(s) of evaluation of this end point: 2 years following the last patient recruited	—

Countries

Austria, Belgium, France, Germany, Italy, Sweden, United Kingdom

Contacts

Public ContactSIOP CNS GCT II-Studienleitung

Universitätsklinikum Münster

Gabriele.Calaminus@ukmuenster.de004915144048563

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026