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Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I)

Primary Purpose

Medulloblastoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sonidegib
Cisplatin
Lomustine
Vincristine
radiotherapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medulloblastoma focused on measuring brain, medullobalstoma, MRI, radiotherapy, biomarkers

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed, histologically proven, genetically classified, centrally confirmed medulloblastoma (WNT M0-1, SHH M0-1 (p53wt), Group 4 M0-1)
  • Molecular subtype: medulloblastoma, SHH-activated and TP53-wildtype, M0-1; medulloblastoma, WNT-activated, M0-1; medulloblastoma, Group 4, M0-1
  • Histologic subtype: medulloblastoma, classic (CMB); medulloblastoma, desmoplastic/nodular (DNMB); medulloblastoma, with extensive nodularity (MBEN); medulloblastoma, large cell/anaplastic (LCA)
  • Adult (18 years and above): in WNT-activated and Group 4 medulloblastoma
  • Post-pubertal, defined as females with a bone age of at least 15 years and males with a bone age of at least 17 years, or adult (greater than 18 y of age) (see appendix N) in SHH-activated and TP53-wildtype medulloblastoma
  • Availability of prognostic markers (MYC/MYCN amplification, MYC/MYCN mutation)
  • Availability of paraffin embedded tumour tissue (FFPE) (1 block or 30 unstained slides) and whole blood sample (10 ml) for central review
  • For patients with SHH activated tumours: exclusion of germline alteration of TP53, PTCH, SUFU, BRCA2 and PALB2 if known before randomization
  • Clinical status within 2 weeks of randomization: Karnofsky 50-100. NANO-score 0 to 9 (allowing full-blown cerebellar symptoms)
  • Clinically standard-risk (centrally assessed MRI review) defined as: total or near total surgical resection with less than or equal to 1.5 cm2 (measured in axial plane) of residual tumour on early post-operative MRI, without and with contrast; no CNS metastasis on MRI (cranial and spinal); Chang stage M0-1 with no clinical evidence of extra-CNS metastasis
  • Full recovery from surgery or any post-surgical complication (e.g. Bleeding, infections etc)
  • Pre-surgery and/or post-surgery MRI available.
  • Baseline brain MRI and spinal MRI available within 2 weeks of randomization.
  • Normal liver, renal and haematological function within 2 weeks of randomization.
  • WBC greater than or equal to 3×10^9/L
  • ANC greater than or equal to 1.5×10^9/L
  • Platelet count of greater than or equal to 100×10^9/L independent of transfusion
  • Hemoglobin greater than or equal to 10 g/dl
  • Total Bilirubin less than or equal to 1.5 ULN
  • ALT (SGPT), AST (SGOT), alkaline phosphatase (ALP) less than or equal to 2.5 × ULN
  • Serum creatinine less than 1.5 x ULN or creatinine clearance (CrCl) greater than 30 mL/min (using the Cockcroft-Gault formula)
  • Negative serum or urine pregnancy test within 7 days of randomization for WOCBP.
  • Patients of childbearing / reproductive potential (WOCBP) must use two methods of adequate birth control, including a highly effective method and a barrier method during the study treatment period and for at least 20 months after the last study treatment is mandatory for the patients that received sonidegib, for all other patients this period is at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Male patients even those who have had a vasectomy must always use a condom during treatment and for 6 months after last treatment. Men should not donate semen during treatment and for at least 6 months after ending treatment (donation of semen for the semen analyses of the fertility project 1 b is allowed). Appendix H.
  • Female subjects who are breast feeding must discontinue nursing prior to the first dose of study treatment and until 20 months after the last study treatment.
  • Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. For patients less than 18 years of age, consent has to be obtained from the parent(s) or legal representative.

Exclusion Criteria:

  • Prior treatment for medulloblastoma
  • Unavailability of central review pathology results.
  • Inability to start radiotherapy within 43 days of surgery
  • Significant sensorineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing impairment greater than or equal to 20 dB at 1-3 kHz
  • Any medical contraindication to radiotherapy or chemotherapy.
  • Hypersensitivity to contrast medium for MRI.
  • Hypersensitivity towards the active substance of any of study drugs or their excipients
  • Prior or current use of mitoxantrone, methotrexate, topotecan, imatinib, irinotecan or statins
  • Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, psychiatric disorder) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
  • Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical carcinoma in situ, low risk prostate cancer (cT1-2a N0 and Gleason score less than or equal to 6 and PSA less than 10 ng/mL), either totally resected or irradiated with curative intent (with PSA of less than or equal to 0.1 ng/mL) or under active surveillance as per ESMO guidelines. Other cancers for which the subject has completed potentially curative treatment more than 5 years prior to diagnosis of medulloblastoma study entry are allowed
  • Known history or current evidence of active Hepatitis B (e.g., positive HBV surface antigen) or C (e.g., HCV RNA [qualitative] is detected)
  • Known or current evidence of Human Immunodeficiency Virus (HIV) infection (positive HIV-1/2 antibodies)
  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.

Sites / Locations

  • Royal Adelaide HospitalRecruiting
  • Princess Alexandra Hospital - University Of QueenslandRecruiting
  • Peter Maccallum Cancer InstituteRecruiting
  • Royal North Shore HospitalRecruiting
  • Knappschaft Krankenhaus LangendreerRecruiting
  • Universitaetsklinikum BonnRecruiting
  • Universitaetsklinikum Carl Gustav CarusRecruiting
  • HELIOS Kliniken - HELIOS Klinikum Erfurt GmbHRecruiting
  • Universitaetsklinikum - EssenRecruiting
  • University Frankfurt - Goethe Univ. - University Hospital Frankfurt -Senckenberg Institute of NeurooncologyRecruiting
  • Universitaetsklinikum Freiburg - Klinik fuer NeurochirurgieRecruiting
  • Universitaetsmedizin Goettingen - Georg-August UniversitaetRecruiting
  • Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer CenterRecruiting
  • Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head HospitalRecruiting
  • Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und RadioonkologieRecruiting
  • Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical CenterRecruiting
  • UniversitaetsMedizin MannheimRecruiting
  • Klinikum Rechts der isar Der Technische Universitaet MuenchenRecruiting
  • Ludwig-Maximilians-Universitaet Muenchen - Campus GrosshadernRecruiting
  • Universitaetskliniken Regensburg - Universitaetsklinikum RegensburgRecruiting
  • Universitaetsklinikum Tuebingen- Crona KlinikenRecruiting
  • University Hospital zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

standard arms

experimental arms

Arm Description

Criteria: Adult SHH (p53wt) M0-1, adult WNT M0-1, adult Group 4 M0-1. Radiotherapy to the cranio-spinal axis of 35.2 Gy in 22 daily fractions of 1.6 Gy, followed by an additional boost to the tumour site of 19.8 Gy in 11 daily fractions of 1.8 Gy, summing up to a total dose of 55.0 Gy in 33 daily fractions of 1.6/1.8 Gy. Criteria: Post pubertal < 18 y SHH (p53wt) M0. Radiotherapy to the cranio-spinal axis of 23.4 Gy in 13 daily fractions of 1.8 Gy, followed by an additional boost to the tumour site of 30.6 Gy in 17 daily fractions of 1.8 Gy, summing up to a total dose of 54.0 Gy in 30 daily fractions of 1.8 Gy.

Radiotherapy Criteria: Adult and post-pubertal SHH (p53wt) M0; adult WNT M0, adult Group 4 M0. Radiotherapy to the cranio-spinal axis of 23.4 Gy in 13 daily fractions of 1.8 Gy, followed by an additional boost to the tumour site of 30.6 Gy in 17 daily fractions of 1.8 Gy, summing up to a total dose of 54.0 Gy in 30 daily fractions of 1.8 Gy. SMO-inhibitor Criteria: Adult and post-pubertal SHH (p53wt) M0. Sonidegib 200 mg/day (daily) from first day of radio-chemotherapy until end of maintenance chemotherapy, including 6w chemotherapy break.

Outcomes

Primary Outcome Measures

Progression Free Survival
compare progression-free survival (PFS) by central review of a personalized intensity-modulated therapy (experimental arm; sonidegib) vs. standard therapy in the SHH-activated subgroup in post-pubertal patients with newly diagnosed standard risk medulloblastoma.

Secondary Outcome Measures

Progression Free Survival (PFS)
overall survival (OV)
safety and tolerability profile: CTCAE
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting (with neurological, kidney, auditory, endocrine and radiotherapy associated as AE of special interest). The highest CTCAE v. 5 grading per cycle and per patient will be computed at the EORTC HQ for analysis . Safety and tolerability analyses will be performed in the safety population. Severe grades (3/4) which did not resolve after treatment discontinuation or emerged during follow-up will be identified and listed.
health-related quality of life (HRQoL)
The primary HRQoL endpoint that is considered relevant for this study is social functioning. The other scales from the QLQ-C30 and BN20 will be considered as exploratory in nature. A difference of 10 points on the 100-point QLQ-C30 social functioning scale between the two arms will be considered as clinically relevant.
overall survival

Full Information

First Posted
April 1, 2020
Last Updated
August 11, 2023
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT04402073
Brief Title
Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma
Acronym
PersoMed-I
Official Title
Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma (PersoMed-I)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2022 (Actual)
Primary Completion Date
March 1, 2030 (Anticipated)
Study Completion Date
March 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Medulloblastoma is a rare brain malignancy, mainly affecting children. Treatment of this rapidly growing tumor begins with maximal surgical removal plus radiation and chemotherapy. Treatment toxicity is high. Post-pubertal and pediatric medulloblastomas are biologically and prognostically different, which mandates age-adapted treatment strategies. Patients after puberty bear an intermediate to high prognostic risk. This means that a large number of these patients, are faced with death and/or disability (mainly neurocognitive). Therefore, the scientific and medical need is high. One of the genetic subgroups of medulloblastoma, the SHH-subgroup (Sonic HedgeHog- subgroup), is highly overrepresented in medulloblastoma patients after puberty. This subgroup can be treated with a targeted therapy. The investigators will therefore randomize patients and treat SHH-subgroup patients with sonidegib and a reduction of radiotherapy dose in the experimental arm of the trial. The hypothesis that this personalized risk-adapted therapy will improve outcomes in view of increased efficacy and decreased toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma
Keywords
brain, medullobalstoma, MRI, radiotherapy, biomarkers

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase II, comparative, randomized (experimental : standard arm 1:1, no blinding, no active or placebo control, parallel group, therapeutic
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard arms
Arm Type
Other
Arm Description
Criteria: Adult SHH (p53wt) M0-1, adult WNT M0-1, adult Group 4 M0-1. Radiotherapy to the cranio-spinal axis of 35.2 Gy in 22 daily fractions of 1.6 Gy, followed by an additional boost to the tumour site of 19.8 Gy in 11 daily fractions of 1.8 Gy, summing up to a total dose of 55.0 Gy in 33 daily fractions of 1.6/1.8 Gy. Criteria: Post pubertal < 18 y SHH (p53wt) M0. Radiotherapy to the cranio-spinal axis of 23.4 Gy in 13 daily fractions of 1.8 Gy, followed by an additional boost to the tumour site of 30.6 Gy in 17 daily fractions of 1.8 Gy, summing up to a total dose of 54.0 Gy in 30 daily fractions of 1.8 Gy.
Arm Title
experimental arms
Arm Type
Experimental
Arm Description
Radiotherapy Criteria: Adult and post-pubertal SHH (p53wt) M0; adult WNT M0, adult Group 4 M0. Radiotherapy to the cranio-spinal axis of 23.4 Gy in 13 daily fractions of 1.8 Gy, followed by an additional boost to the tumour site of 30.6 Gy in 17 daily fractions of 1.8 Gy, summing up to a total dose of 54.0 Gy in 30 daily fractions of 1.8 Gy. SMO-inhibitor Criteria: Adult and post-pubertal SHH (p53wt) M0. Sonidegib 200 mg/day (daily) from first day of radio-chemotherapy until end of maintenance chemotherapy, including 6w chemotherapy break.
Intervention Type
Drug
Intervention Name(s)
Sonidegib
Intervention Description
Sonidegib is a selective smoothened inhibitor that inhibits the sonic hedgehog-signaling pathway. It is used in patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin (CIS) is a platinum derivate used in the treatment in several epithelial tumours. The application route is through the veins.
Intervention Type
Drug
Intervention Name(s)
Lomustine
Intervention Description
Lomustine is a nitrosourea used in the treatment of brain tumours and Hodgkin's disease. The application route is oral.
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
Vincristine sulfate (VCR) is an inhibitor of microtubule formation in the mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage. Vincristine sulfate is indicated in acute leukemia, Hodgkin's disease, non-Hodgkin's lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor. The application route is through the vein.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
Radiotherapy to the cranio-spinal axis of 35.2 Gy in 22 daily fractions of 1.6 Gy, followed by an additional boost to the tumour site of 19.8 Gy in 11 daily fractions of 1.8 Gy, summing up to a total dose of 55.0 Gy in 33 daily fractions of 1.6/1.8 Gy.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
compare progression-free survival (PFS) by central review of a personalized intensity-modulated therapy (experimental arm; sonidegib) vs. standard therapy in the SHH-activated subgroup in post-pubertal patients with newly diagnosed standard risk medulloblastoma.
Time Frame
91 months after the date of recruitment of the first patient
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Time Frame
when 43 PFS events are observed which is estimated to occur 91 months after the date of recruitment of the first patient.
Title
overall survival (OV)
Time Frame
when 43 PFS events are observed which is estimated to occur 91 months after the date of recruitment of the first patient.
Title
safety and tolerability profile: CTCAE
Description
This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting (with neurological, kidney, auditory, endocrine and radiotherapy associated as AE of special interest). The highest CTCAE v. 5 grading per cycle and per patient will be computed at the EORTC HQ for analysis . Safety and tolerability analyses will be performed in the safety population. Severe grades (3/4) which did not resolve after treatment discontinuation or emerged during follow-up will be identified and listed.
Time Frame
when 43 PFS events are observed which is estimated to occur 91 months after the date of recruitment of the first patient.
Title
health-related quality of life (HRQoL)
Description
The primary HRQoL endpoint that is considered relevant for this study is social functioning. The other scales from the QLQ-C30 and BN20 will be considered as exploratory in nature. A difference of 10 points on the 100-point QLQ-C30 social functioning scale between the two arms will be considered as clinically relevant.
Time Frame
when 43 PFS events are observed which is estimated to occur 91 months after the date of recruitment of the first patient.
Title
overall survival
Time Frame
when 43 PFS events are observed which is estimated to occur 91 months after the date of recruitment of the first patient.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed, histologically proven, genetically classified, centrally confirmed medulloblastoma (WNT M0-1, SHH M0-1 (p53wt), Group 4 M0-1) Molecular subtype: medulloblastoma, SHH-activated and TP53-wildtype, M0-1; medulloblastoma, WNT-activated, M0-1; medulloblastoma, Group 4, M0-1 Histologic subtype: medulloblastoma, classic (CMB); medulloblastoma, desmoplastic/nodular (DNMB); medulloblastoma, with extensive nodularity (MBEN); medulloblastoma, large cell/anaplastic (LCA) Adult (18 years and above): in WNT-activated and Group 4 medulloblastoma Post-pubertal, defined as females with a bone age of at least 15 years and males with a bone age of at least 17 years, or adult (greater than 18 y of age) (see appendix N) in SHH-activated and TP53-wildtype medulloblastoma Availability of prognostic markers (MYC/MYCN amplification, MYC/MYCN mutation) Availability of paraffin embedded tumour tissue (FFPE) (1 block or 30 unstained slides) and whole blood sample (10 ml) for central review For patients with SHH activated tumours: exclusion of germline alteration of TP53, PTCH, SUFU, BRCA2 and PALB2 if known before randomization Clinical status within 2 weeks of randomization: Karnofsky 50-100. NANO-score 0 to 9 (allowing full-blown cerebellar symptoms) Clinically standard-risk (centrally assessed MRI review) defined as: total or near total surgical resection with less than or equal to 1.5 cm2 (measured in axial plane) of residual tumour on early post-operative MRI, without and with contrast; no CNS metastasis on MRI (cranial and spinal); Chang stage M0-1 with no clinical evidence of extra-CNS metastasis Full recovery from surgery or any post-surgical complication (e.g. Bleeding, infections etc) Pre-surgery and/or post-surgery MRI available. Baseline brain MRI and spinal MRI available within 2 weeks of randomization. Normal liver, renal and haematological function within 2 weeks of randomization. WBC greater than or equal to 3×10^9/L ANC greater than or equal to 1.5×10^9/L Platelet count of greater than or equal to 100×10^9/L independent of transfusion Hemoglobin greater than or equal to 10 g/dl Total Bilirubin less than or equal to 1.5 ULN ALT (SGPT), AST (SGOT), alkaline phosphatase (ALP) less than or equal to 2.5 × ULN Serum creatinine less than 1.5 x ULN or creatinine clearance (CrCl) greater than 30 mL/min (using the Cockcroft-Gault formula) Negative serum or urine pregnancy test within 7 days of randomization for WOCBP. Patients of childbearing / reproductive potential (WOCBP) must use two methods of adequate birth control, including a highly effective method and a barrier method during the study treatment period and for at least 20 months after the last study treatment is mandatory for the patients that received sonidegib, for all other patients this period is at least 6 months after the last study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Male patients even those who have had a vasectomy must always use a condom during treatment and for 6 months after last treatment. Men should not donate semen during treatment and for at least 6 months after ending treatment (donation of semen for the semen analyses of the fertility project 1 b is allowed). Appendix H. Female subjects who are breast feeding must discontinue nursing prior to the first dose of study treatment and until 20 months after the last study treatment. Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. For patients less than 18 years of age, consent has to be obtained from the parent(s) or legal representative. Exclusion Criteria: Prior treatment for medulloblastoma Unavailability of central review pathology results. Inability to start radiotherapy within 43 days of surgery Significant sensorineural hearing deficit as defined by pure tone audiometry with bone conduction or air conduction and normal tympanogram showing impairment greater than or equal to 20 dB at 1-3 kHz Any medical contraindication to radiotherapy or chemotherapy. Hypersensitivity to contrast medium for MRI. Hypersensitivity towards the active substance of any of study drugs or their excipients Prior or current use of mitoxantrone, methotrexate, topotecan, imatinib, irinotecan or statins Concurrent severe or uncontrolled medical disease (e.g., active systemic infection, diabetes, psychiatric disorder) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical carcinoma in situ, low risk prostate cancer (cT1-2a N0 and Gleason score less than or equal to 6 and PSA less than 10 ng/mL), either totally resected or irradiated with curative intent (with PSA of less than or equal to 0.1 ng/mL) or under active surveillance as per ESMO guidelines. Other cancers for which the subject has completed potentially curative treatment more than 5 years prior to diagnosis of medulloblastoma study entry are allowed Known history or current evidence of active Hepatitis B (e.g., positive HBV surface antigen) or C (e.g., HCV RNA [qualitative] is detected) Known or current evidence of Human Immunodeficiency Virus (HIV) infection (positive HIV-1/2 antibodies) Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
EORTC HQ
Phone
003227741611
Email
eortc@eortc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hau
Organizational Affiliation
EORTC study coordinator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eryn Dow
Facility Name
Princess Alexandra Hospital - University Of Queensland
City
Brisbane
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rick Walker
Facility Name
Peter Maccallum Cancer Institute
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Whittle
Facility Name
Royal North Shore Hospital
City
Sydney
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Wheeler
Facility Name
Knappschaft Krankenhaus Langendreer
City
Bochum
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Seidel
First Name & Middle Initial & Last Name & Degree
Sabine Seidel, MD
Facility Name
Universitaetsklinikum Bonn
City
Bonn
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrich Herrlinger, MD
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietmar Krex
First Name & Middle Initial & Last Name & Degree
Dietmar Krex, MD
Facility Name
HELIOS Kliniken - HELIOS Klinikum Erfurt GmbH
City
Erfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruediger Gerlach
First Name & Middle Initial & Last Name & Degree
Ruediger Gerlach, MD
Facility Name
Universitaetsklinikum - Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Glas, MD
First Name & Middle Initial & Last Name & Degree
Martin Glas, MD
First Name & Middle Initial & Last Name & Degree
Gudrun Fleischhack, MD
Facility Name
University Frankfurt - Goethe Univ. - University Hospital Frankfurt -Senckenberg Institute of Neurooncology
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Becker
First Name & Middle Initial & Last Name & Degree
Martina Becker, MD
First Name & Middle Initial & Last Name & Degree
Michael Burger, MD
Facility Name
Universitaetsklinikum Freiburg - Klinik fuer Neurochirurgie
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Schnell
First Name & Middle Initial & Last Name & Degree
Oliver Schnell, MD
First Name & Middle Initial & Last Name & Degree
Miriam van Buiren, MD
Facility Name
Universitaetsmedizin Goettingen - Georg-August Universitaet
City
Goettigen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christof Kramm, MD
Facility Name
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malte Mohme, MD
First Name & Middle Initial & Last Name & Degree
Martin Mynarek, MD
Facility Name
Universitaetsklinikum Heidelberg - UniversitaetsKlinikum Heidelberg - Head Hospital
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antje Wick, MD
Facility Name
Universitaetsklinikum Leipzig-Klinik fuer Strahlentherapie und Radioonkologie
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clemens Seidel, MD
Facility Name
Univ. Mainz - Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz-University Medical Center
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Ringel
First Name & Middle Initial & Last Name & Degree
Jörg Faber, MD
First Name & Middle Initial & Last Name & Degree
Florian Ringel, MD
Facility Name
UniversitaetsMedizin Mannheim
City
Mannheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Karremann
First Name & Middle Initial & Last Name & Degree
Michael Karremann, MD
First Name & Middle Initial & Last Name & Degree
Iris Mildenberger, MD
Facility Name
Klinikum Rechts der isar Der Technische Universitaet Muenchen
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Combs
First Name & Middle Initial & Last Name & Degree
Stephanie Combs, MD
Facility Name
Ludwig-Maximilians-Universitaet Muenchen - Campus Grosshadern
City
Munich
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louisa von Baumgarten
First Name & Middle Initial & Last Name & Degree
Louisa von Baumgarten, MD
Facility Name
Universitaetskliniken Regensburg - Universitaetsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hau, MD
First Name & Middle Initial & Last Name & Degree
Marcus Jakob, MD
First Name & Middle Initial & Last Name & Degree
Peter Hau, MD
First Name & Middle Initial & Last Name & Degree
Marcus Jakob, MD
Facility Name
Universitaetsklinikum Tuebingen- Crona Kliniken
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghazaleh Tabatabai
First Name & Middle Initial & Last Name & Degree
Ghazaleh Tabatabai, MD
First Name & Middle Initial & Last Name & Degree
Thomas Eichholz, MD
Facility Name
University Hospital zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Weller, PI

12. IPD Sharing Statement

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Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma

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