SIOP CNS GCT II

автор: J. Dobke, erstellt am: 2011/11/07, Последнее изменение: 2015/06/15

титул SIOP CNS GCT II: Prospective Trial for the diagnosis and treatment of children, adolescents and young adults with Intracranial Germ Cell Tumours
Формы рака Intracranial Germ Cell Tumours
Вид исследования Prospective, non-randomised multicentre study with patients stratified according to risk groups
Цель исследования

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

NON-GERMINOMA (± TERATOMA)

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
Лечение

Germinoma

Chemotherapy:

Non-metastatic fully staged germinoma (± teratoma)
Two courses (1 and 3) of Etoposide and Carboplatin, alternating with two courses (2 and 4) of Etoposide and Ifosfamide
Note: Bifocal germinoma (pineal+suprasellar) are treated as non-metastatic germinoma, if staging shows no additional dissemination

Metastatic or incompletely staged germinomas (± teratoma)
Do not receive chemotherapy in this protocol

Radiotherapy:

Non-metastatic pure germinoma in PR/SD
After Chemotherapy: 24 Gy (15 fractions) to whole ventricles with a 16 Gy (10 fraction) boost to tumour bed (total tumour dose 40 Gy)

Non-metastatic germinoma in CR
After Chemotherapy: 24 Gy (15 fractions) to whole ventricles

Metastatic or incompletely staged pure germinoma
24 Gy (15 fractions) to craniospinal axis with a 16 Gy (10 fraction) boost to tumour bed and any intracranial metastases and spinal deposits (total tumour dose 40 Gy)

Non-metastatic germinoma plus teratoma (incompletely resected)
After Chemotherapy: 24 Gy (15 fractions) to whole ventricles; 30.4 Gy (19 fraction) boost to tumour bed (total tumour dose 54.4 Gy)

Metastatic germinoma plus teratoma (incompletely resected)
24 Gy (15 fractions) to craniospinal axis ; 30.4 Gy (19 fraction) boost to tumour bed and 16 Gy (10 frac-tion) boost to metastases (total tumour dose 54.4 Gy)

NON- GERMINOME (± TERATOM)

Chemotherapie:

Standard-Risiko nicht-germinomatöse maligne Keimzelltumoren
Vier Kurse Etoposid, Cisplatin und Ifosfamid (Standardbehandlung)

Hoch-Risiko nicht-germinomatöse maligne Keimzelltumoren
Zwei Kurse Standarddosen Etoposid, Cisplatin und Ifosfamid, gefolgt von zwei dosisintensivierten Kursen Etoposid, Cisplatin und Ifosfamid mit Stammzellsupport
Resektion von Resttumor nach drei Kursen Chemotherapie (wenn indiziert) gefolgt vom vierten Kurs Chemotherapie. Wenn vitale Tumorzellen im Resektat gefunden wurden, wird der Patient der Hoch-Risikogruppe zugeführt.

Radiotherapie

Standard-Risiko und Hoch-Risiko nicht-germinomatöse maligne Keimzelltumoren:

Patienten mit lokalisierter Erkrankung bei Diagnose
Nach Chemotherapie: 54 Gy fokale Bestrahlung (30 Fraktionen)

Patienten mit metastatischer Erkrankung bei Diagnose
Nach Chemotherapie: 30 Gy (20 Fraktionen) kraniospinal mit 24 Gy (15 Fraktionen) Boost des Tumorgebietes sowie jeder intrakranialen Metastase Gesamttumordosis 54Gy) und 20.8 Gy (13 Fraktionen) Boost der spinalen Metastasen (Gesamtdosis 50.8 Gy)

Кого берут в протокол
  • 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
Кого не берут в протокол
  • 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
Сколько пациентов должно пройти через исследование 400 malignant germ cell tumours
Status October 2011-October 2016 (Ende dof recrutation)
EudraCT 2009-018072-33
Entry Study Register ClinicalTrials.gov: NCTNCT01424839
Руководитель протокола Dr. Gabriele Calaminus
E-Mail mailto:makei@uni-muenster.de
С кем можно связаться

Coordinating Investigator

Dr. med. Gabriele Calaminus
Universitätsklinikum Bonn Zentrum für Kinderheilkunde
Päd. Hämatologie/ Onkologie
Konrad-Adenauer-Allee 119
53113 Bonn
Telefon +49 (228) 287 33305
Fax +49 (228) 287 33605
Gabriele.Calaminus@ukb.uni-bonn.de

Data management

Carmen Teske

Reference pathology

Dr. med. Christian Vokuhl
Institut für Pathologie der Universität Kiel
Sektion Kinderpathologie, Haus 14
Arnold-Heller-Str. 3
24105 Kiel
Telefon +49 (431) 500 15603
Fax +49 (431) 500 15604
cvokuhl@path.uni-kiel.de

Prof. Dr. med. Torsten Pietsch
Institut für Neuropathologie
ME der Universität
Sigmund-Freud-Str. 25
53105 Bonn
Telefon +49 (228) 287 16602
Fax +49 (228) 287 14331
t.pietsch@uni-bonn.de

Reference radiology

Prof. Dr. Monika Warmuth-Metz
Universitätsklinikum Würzburg
Abt. für Neuroradiologie
Josef-Schneider-Str. 11
97080 Würzburg
Telefon +49 (931) 201 34799
Fax +49 (931) 201 34789
hit@ukw.de

Участники исследования GPOH, Frankreich, Italien, Dänemark, Schweden, Norwegen, Finnland, Spanien, Niederlande, Großbritannien
Кто финансирует Deutsche Kinderkrebsstiftung