Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02066220 : International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma
PhasePhase 2/Phase 3
AgesMin: 3 Years Max: 21 Years
Eligibility
Inclusion Criteria:

1. Age at diagnosis, at least 3 - 5 years (depending on the country) and less than 22
years (LR-arm: less than 16 years). The date of diagnosis is the date on which surgery
is undertaken.

2. Histologically proven medulloblastoma, including the following subtypes, as defined in
the WHO classification (2007): classic medulloblastoma, desmoplastic/nodular
medulloblastoma. Pre-treatment central pathology review is considered mandatory.

3. Standard-risk medulloblastoma, defined as;

- total or near total surgical resection with less than or equal to 1.5 cm2
(measured on axial plane) of residual tumour on early post-operative MRI, without
and with contrast, on central review;

- no central nervous system (CNS) metastasis on MRI (cranial and spinal) on central
review;

- no tumour cells on the cytospin of lumbar CSF

- no clinical evidence of extra-CNS metastasis; Patients with a reduction of
postoperative residual tumor through second surgery to less than or equal to 1.5
cm2 are eligible, if if timeline for start of radiotherapy can be kept.

4. Submission of high quality biological material including fresh frozen tumor samples
for the molecular assessment of biological markers (such as the assessment of
myelocytomatosis oncogene (MYC) copy number status) in national biological reference
centers. Submission of blood is mandatory for all patients, who agree on germline DNA
studies. Submission of CSF is recommended.

5. No amplification of MYC or MYCN (determined by FISH).

6. For LR-arm: Low-risk biological profile, defined as WNT subgroup positivity. The WNT
subgroup is defined by the presence of (i) ß-catenin mutation (mandatory testing), or
(ii) ß-catenin nuclear immuno-positivity by IHC (mandatory testing) and ß-catenin
mutation, or (iii) ß-catenin nuclear immuno-positivity by IHC and monosomy 6 (optional
testing).

For SR-arm: average-risk biological profile, defined as ß-catenin nuclear
immuno-negativity by IHC (mandatory) and mutation analysis (optional).

7. No prior therapy for medulloblastoma other than surgery.

8. Radiotherapy aiming to start no more than 28 days after surgery. Foreseeable inability
to start radiotherapy within 40 days after surgery renders patients ineligible for the
study.

9. Screening for the compliance with eligibility criteria should be completed, and
patient should be included into the study within 28 days after first surgery (in case
of second surgery within 35 days after first surgery). Inclusion of patients is not
possible later than 40 days after first tumour surgery, or after start of
radiotherapy.

10. Common toxicity criteria (CTC) grades < 2 for liver, renal, haematological function

11. no significant sensorineural hearing deficit as defined by pure tone audiometry with
bone conduction or air conduction and normal tympanogram showing no impairment ? 20
decibel (dB) at 1-3 kilohertz (kHz). If performance of pure tone audiometry is not
possible postoperatively, normal otoacoustic emissions are acceptable, if there is no
history for hearing deficit.

12. No medical contraindication to radiotherapy or chemotherapy, such as preexisting DNA
breakage syndromes (e.g. Fanconi Anemia, Nijmegen breakage syndrome), Gorlin Syndrome
or other reasons as defined by patient's clinician.

13. No identified Turcot and Li Fraumeni syndrome.

14. Written informed consent (and patient assent where appropriate) for therapy according
to the laws of each participating country. Information must be provided to the patient
on biological studies (tumour and germline), and written informed consent obtained of
agreement for participation.

15. National and local ethical committee approval according to the laws of each
participating country (to include approval for biological studies).

Exclusion Criteria:

1. One of the inclusion criteria is lacking.

2. Brainstem or supratentorial primitive neuro-ectodermal tumour.

3. Atypical teratoid rhabdoid tumour.

4. Medulloepithelioma; Ependymoblastoma

5. Large-cell medulloblastoma, anaplastic medulloblastoma, or medulloblastoma with
extensive nodularity (MBEN), centrally confirmed.

6. Unfavourable or undeterminable biological profile, defined as amplification of MYC or
MYCN, or MYC or MYCN or WNT subgroup status not determinable.

7. Metastatic medulloblastoma (on CNS MRI and/or positive cytospin of postoperative
lumbar CSF).

8. Patient previously treated for a brain tumour or any type of malignant disease.

9. DNA breakage syndromes (e.g. Fanconi anemia, Nijmegen breakage syndrome) or other, or
identified Gorlin,Turcot, or Li Fraumeni syndrome.

10. Patients who are pregnant.

11. Female patients who are sexually active and not taking reliable contraception.

12. Patients who cannot be regularly followed up due to psychological, social, familial or
geographic reasons.

13. Patients in whom non-compliance with toxicity management guidelines can be expected.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02066220      |      Link to official Clinicaltrials.gov listing
Locations
Graz,
Austria

Facility: Medical University of Graz
Investigator:
Contact: Martin Benesch, Dr.
Click HERE to send email to this center

Leuven,
Belgium

Facility: University Hospital Gasthuisberg
Investigator:
Contact: Sandra Jacobs, Prof.
Click HERE to send email to this center

Grenoble,
France

Facility: CHU de Grenoble
Investigator:
Contact:
Email not avaialable

Paris Cedex 05,
France

Facility: Institute Curie
Investigator:
Contact: Francois Doz, Prof. Dr.
Click HERE to send email to this center

Tours,
France

Facility: CHU-TOURS - Hôpital Clocheville
Investigator:
Contact:
Email not avaialable

Vandoeuvre Les Nancy,
France

Facility: Hôpital NANCY-BRABOIS
Investigator:
Contact:
Email not avaialable

Aachen,
Germany

Facility: University Hospital Aachen
Investigator:
Contact:
Email not avaialable

Augsburg,
Germany

Facility: Klinikum Augsburg
Investigator:
Contact:
Email not avaialable

Berlin,
Germany

Facility: Helios Klinikum Berlin-Buch
Investigator:
Contact:
Email not avaialable

Berlin,
Germany

Facility: Charite Campus, University of Berlin
Investigator:
Contact:
Email not avaialable

Bielefeld,
Germany

Facility: Evangelisches Krankenhaus Bielefeld
Investigator:
Contact:
Email not avaialable

Bonn,
Germany

Facility: University Hospital Bonn
Investigator:
Contact:
Email not avaialable

Braunschweig,
Germany

Facility: Klinikum Braunschweig
Investigator:
Contact:
Email not avaialable

Bremen,
Germany

Facility: Klinikum Bremen-Mitte
Investigator:
Contact:
Email not avaialable

Chemnitz,
Germany

Facility: Klinikum Chemnitz
Investigator:
Contact:
Email not avaialable

Cologne,
Germany

Facility: University Hospital Cologne
Investigator:
Contact:
Email not avaialable

Cottbus,
Germany

Facility: Carl-Thiem-Klinikum Cottbus
Investigator:
Contact:
Email not avaialable

Datteln,
Germany

Facility: Vestische Kinder- und Jugendklinik, University Witten/Herdecke
Investigator:
Contact:
Email not avaialable

Dortmund,
Germany

Facility: Klinikum Dortmund
Investigator:
Contact:
Email not avaialable

Dresden,
Germany

Facility: University Hospital Dresden
Investigator:
Contact:
Email not avaialable

Duisburg,
Germany

Facility: Klinikum Duisburg
Investigator:
Contact:
Email not avaialable

Düsseldorf,
Germany

Facility: University Hospital Düsseldorf
Investigator:
Contact:
Email not avaialable

Erfurt,
Germany

Facility: HELIOS Klinikum-Erfurt
Investigator:
Contact:
Email not avaialable

Erlangen,
Germany

Facility: University Hospital Erlangen
Investigator:
Contact:
Email not avaialable

Essen,
Germany

Facility: University Hospital Essen
Investigator:
Contact:
Email not avaialable

Frankfurt,
Germany

Facility: University Hospital Frankfurt/Main
Investigator:
Contact:
Email not avaialable

Freiburg,
Germany

Facility: University Hospital Freiburg
Investigator:
Contact:
Email not avaialable

Gießen,
Germany

Facility: University Hospital Gießen and Marburg
Investigator:
Contact:
Email not avaialable

Göttingen,
Germany

Facility: University Hospital Göttingen
Investigator:
Contact:
Email not avaialable

Greifswald,
Germany

Facility: University Hospital Greifswald
Investigator:
Contact:
Email not avaialable

Halle,
Germany

Facility: University Hospital Halle/Saale
Investigator:
Contact:
Email not avaialable

Hamburg,
Germany

Facility: University Medical Center Hamburg-Eppendorf
Investigator:
Contact: Stefan Rutkowski, Prof. Phone: +49-40-7410
Click HERE to send email to this center

Hannover,
Germany

Facility: Medizinische Hochschule Hannover
Investigator:
Contact:
Email not avaialable

Heidelberg,
Germany

Facility: Angelika-Lautenschläger-Klinik
Investigator:
Contact:
Email not avaialable

Herdecke,
Germany

Facility: Gemeinschaftskrankenhaus Herdecke
Investigator:
Contact:
Email not avaialable

Homburg,
Germany

Facility: University Hospital Homburg/Saar
Investigator:
Contact:
Email not avaialable

Jena,
Germany

Facility: University Hospital Jena
Investigator:
Contact:
Email not avaialable

Karlsruhe,
Germany

Facility: Städtisches Klinikum Karlsruhe
Investigator:
Contact:
Email not avaialable

Kassel,
Germany

Facility: Klinikum Kassel
Investigator:
Contact:
Email not avaialable

Kiel,
Germany

Facility: UK-SH Campus Kiel
Investigator:
Contact:
Email not avaialable

Koblenz,
Germany

Facility: Gemeinschaftsklinikum Koblenz-Mayen
Investigator:
Contact:
Email not avaialable

Krefeld,
Germany

Facility: HELIOS Klinikum Krefeld
Investigator:
Contact:
Email not avaialable

Leipzig,
Germany

Facility: University Hospital Leipzig
Investigator:
Contact:
Email not avaialable

Lübeck,
Germany

Facility: University Hospital Lübeck
Investigator:
Contact:
Email not avaialable

Magdeburg,
Germany

Facility: University Hospital Magdeburg
Investigator:
Contact:
Email not avaialable

Mainz,
Germany

Facility: University Hospital Mainz
Investigator:
Contact:
Email not avaialable

Mannheim,
Germany

Facility: University Hospital Mannheim
Investigator:
Contact:
Email not avaialable

Minden,
Germany

Facility: Johannes Wesling Klinikum Minden
Investigator:
Contact:
Email not avaialable

München,
Germany

Facility: University Hospital München, Dr. von Haunersches Kinderspital
Investigator:
Contact:
Email not avaialable

München,
Germany

Facility: Klinikum Schwabing, Pediatric Hospital of Technical University
Investigator:
Contact:
Email not avaialable

Münster,
Germany

Facility: University Hospital Münster
Investigator:
Contact:
Email not avaialable

Nürnberg,
Germany

Facility: Cnopf'sche Kinderklinik
Investigator:
Contact:
Email not avaialable

Oldenburg,
Germany

Facility: Klinikum Oldenburg
Investigator:
Contact:
Email not avaialable

Regensburg,
Germany

Facility: University Hospital Regensburg
Investigator:
Contact:
Email not avaialable

Rostock,
Germany

Facility: University Hospital Rostock
Investigator:
Contact:
Email not avaialable

Sankt Augustin,
Germany

Facility: Asklepios Klinik Sankt Augustin
Investigator:
Contact:
Email not avaialable

Schwerin,
Germany

Facility: HELIOS-Kliniken Schwerin
Investigator:
Contact:
Email not avaialable

Stuttgart,
Germany

Facility: Klinikum Stuttgart
Investigator:
Contact:
Email not avaialable

Trier,
Germany

Facility: Mutterhaus der Borromäerinnen
Investigator:
Contact:
Email not avaialable

Tübingen,
Germany

Facility: University Hospital Tübingen
Investigator:
Contact:
Email not avaialable

Ulm,
Germany

Facility: University Hospital Ulm
Investigator:
Contact:
Email not avaialable

Wolfsburg,
Germany

Facility: Klinikum der Stadt Wolfsburg
Investigator:
Contact:
Email not avaialable

Würzburg,
Germany

Facility: University Hospital Würzburg
Investigator:
Contact:
Email not avaialable

Milano,
Italy

Facility: Fondazione IRCCS Istituto Nazionale Tumori
Investigator:
Contact: Maura Massimino, Dr.
Click HERE to send email to this center

Baracaldo,
Spain

Facility: Oncology Hospital Cruces Bilbao
Investigator:
Contact: Aurora Navajas Guitierrez, Prof.
Click HERE to send email to this center

Göteburg,
Sweden

Facility: Barncancercentrum Drottning Silvias Barnochungdomssjukhus
Investigator:
Contact: Birgitta Lannering, Prof.
Click HERE to send email to this center

Zürich,
Switzerland

Facility: University Children's Hospital
Investigator:
Contact: Nicolas Gerber, Dr.
Click HERE to send email to this center

London,
United Kingdom

Facility: Great Ormond Street Hospital
Investigator:
Contact: Antony Michalski, Dr.
Click HERE to send email to this center




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