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International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013) (HIT-HGG-2013)

Primary Purpose

Glioblastoma WHO Grade IV, Diffuse Midline Glioma Histone 3 K27M WHO Grade IV, Anaplastic Astrocytoma WHO Grade III

Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Temozolomide + Valproic Acid
Sponsored by
University of Göttingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma WHO Grade IV focused on measuring Glioblastoma, high grade glioma, brain tumor, Anaplastic astrocytoma, DIPG, Gliomatosis cerebri, Diffuse midline glioma, Valproic acid, Temozolomide

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed, previously untreated diffuse paediatric high grade glioma with central neuropathological review including paedHGG (WHO grade IV) and anaplastic astrocytoma (WHO grade III).
  • Newly diagnosed, previously untreated diffuse intrinsic pontine glioma with central neuroradiological review
  • Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuroradiological review
  • Patient ≥ 3 years and < 18 years of age at time of diagnosis
  • Written informed consent of the patient and/or the patient's parents or legal guardian according to national laws

Exclusion Criteria:

  • Pre-treatment of paedHGG (WHO grade IV), anaplastic astrocytoma (WHO grade III), diffuse intrinsic pontine glioma (as confirmed by neuroradiological review), and gliomatosis cerebri (as confirmed by neuroradiological review).
  • Known hypersensitivity or contraindication to study drugs and/or dacarbazine
  • Prior chemotherapy within the last 30 days before HIT-HGG-2013 treatment or radiotherapy which prevents adequate Performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary high grade glioma after previous malignant brain tumour, e.g. medulloblastoma, ependymoma, craniopharyngeoma. If previous treatment does not prevent the adequate performance of the outlined Treatment protocol patients with secondary high grade glioma will be eligible for the present trial.
  • Other (simultaneous) malignancies
  • Pregnancy and / or lactation
  • Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly)
  • Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial.
  • Clinical (e.g. a constitutional mismatch repair deficiency score ≥ 3; Wimmer et al. 2014) and/or other hints (e.g. absent intratumoral immunohistochemical expression of at least one of the MLH1, MSH2, MSH6, or PMS2 mismatch repair proteins and/or high microsatellite instability) for an underlying biallelic (constitutional) mismatch repair deficiency (bMMRD/CMMRD) or a heterozygous mismatch repair deficiency (hereditary non-polyposis colon cancer syndrome/HNPCC syndrome/Lynch syndrome): These patients and their relatives should be offered human genetic counseling and rapid genetic diagnostics to confirm or rule out These conditions. These patients might not benefit from the present study treatment but maybe from other therapeutic strategies (Bouffet et al. 2016). Since patients with clinically suspected neurofibromatosis type 1 may display similar symptoms as in CMMRD, patients with clinically suspected neurofibromatosis type 1 should be also checked for CMMRD as suggested above.
  • Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism)
  • Severe concomitant diseases (e.g. immune deficiency syndrome; known tumour predisposition syndromes which do not affect adequate performance of the trial represent no exclusion criterion a priori
  • Known HIV positivity
  • Known severe manifest hepatic disease including hepatic porphyria as well as personal or family history of severe hepatic dysfunction, especially drug-related
  • Known severe pancreatic disease
  • Known lethal hepatic dysfunction in a sibling during valproic acid treatment
  • Known urea cycle defect
  • Known mitochondrial diseases caused by genetic mutations within the gene coding for the enzyme polymerase gamma (POLG), e.g. Alpers-Huttenlocher syndrome, as well as suspected POLGrelated disorders in children under the age of two years
  • Known severe coagulation disorders (in regards to thrombopenia see prerequisite for blood cell count before starting treatment)
  • Valproic acid as antiepileptc drug for any pre-existing epilepsy (Exception: Valproic acid treatment due to tumour-related epilepsy will be tolerated, if the time interval between start of valproic acid treatment and trial enrolment is ≤ 8 weeks.

Sites / Locations

  • Universitätsklinik RWTH AachenRecruiting
  • Klinikum AugsburgRecruiting
  • Charité Universitätsmedizin BerlinRecruiting
  • HELIOS Klinikum Berlin BuchRecruiting
  • Evangelisches Krankenhaus BielefeldRecruiting
  • Universitätsklinikum BonnRecruiting
  • Städtisches Klinikum Braunschweig gGmbHRecruiting
  • Klinikum Bremen-Mitte gGmbHRecruiting
  • Carl-Thiem-Klinikum Cottbus gGmbHRecruiting
  • Klinikum Dortmund gGmbHRecruiting
  • Universitätsklinikum Carl Gustav Carus DresdenRecruiting
  • Sana Kliniken Duisburg GmbH - Wedau KlinikenRecruiting
  • HELIOS Klinikum Erfurt GmbHRecruiting
  • Universitätsklinikum ErlangenRecruiting
  • Universitätsklinikum EssenRecruiting
  • Universitätsklinikum FrankfurtRecruiting
  • Universitätsklinikum FreiburgRecruiting
  • Universitätsklinikum Gießen und Marburg GmbHRecruiting
  • Universitätsmedizin GreifswaldRecruiting
  • Universitätsmedizin GöttingenRecruiting
  • Universitätsklinikum HalleRecruiting
  • Universitätsklinikum HamburgRecruiting
  • Medizinische Hochschule HannoverRecruiting
  • Angelika-Lautenschläger-KlinikRecruiting
  • SLK-Kliniken Heilbronn GmbHRecruiting
  • Gemeinschaftskrankenhaus HerdeckeRecruiting
  • Universitätsklinikum des SaarlandesRecruiting
  • Universitätsklinikum JenaRecruiting
  • Städtisches Klinikum KarlsruheRecruiting
  • Gesundheit Nordhessen - Klinikum KasselRecruiting
  • UKSH KielRecruiting
  • Gemeinschaftsklinikum Mittelrhein gGmbHRecruiting
  • HELIOS Klinikum KrefeldRecruiting
  • Kliniken der Stadt Köln gGmbHRecruiting
  • Universitätsklinikum LeipzigRecruiting
  • UKSH Campus LübeckRecruiting
  • Universitätsklinikum Magdeburg A. ö. R.Recruiting
  • Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting
  • UMM Universitätsmedizin MannheimRecruiting
  • Johannes Wesling Klinikum MindenRecruiting
  • Technische Universität München / Klinikum SchwabingRecruiting
  • Universitätsklinikum MünsterRecruiting
  • Klinikum Oldenburg gGmbHRecruiting
  • Universitätsklinikum RegensburgRecruiting
  • Universitäts-Kinder- und Jugendklinik Rostock
  • ASKLEPIOS Klinik St. AugustinRecruiting
  • HELIOS Kliniken Schwerin GmbHRecruiting
  • Klinikum Stuttgart - OlgahospitalRecruiting
  • Universitätsklinikum TübingenRecruiting
  • Universitätsklinikum UlmRecruiting
  • Universitätsklinik WürzburgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temozolomide + Valproic acid

Arm Description

E.g. Valproat-neuraxpharm®, Valproat-neuraxpharm® Lösung, Ergenyl®, Ergenyl®-Lösung oder Orfiril® Saft (Valproic acid), [10 mg/kg/d] tablet oder juice, p.o., every day in parallel to simultaneous radiochemotherapy with cytostatic drug Temodal (Temozolomid): [75 mg/m2/d] during simultaneous radiochemotherapy (7 days a week, max. 49 days); [150-200 mg/m2/d] during consolidation therapy (for 5 days every 28 days, 12 cycles), tablets, p.o. (or powder for preparation of an intravenously applicable solution).

Outcomes

Primary Outcome Measures

Comparison of effects of valproine acid with respect to historical control group.
To confirm that the Event-Free Survival (EFS) in patients ≥ 3 years of age with paed HGG WHO grade IV, anaplastic astrocytoma WHO grade III (AAIII), DIPG, and gliomatosis cerebri differs for children treated with additional VPA compared to children in the historical HIT-HGG-2007 study sample.

Secondary Outcome Measures

Full Information

First Posted
August 4, 2017
Last Updated
June 2, 2022
Sponsor
University of Göttingen
Collaborators
Deutsche Kinderkrebsstiftung, Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03243461
Brief Title
International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)
Acronym
HIT-HGG-2013
Official Title
International Cooperative Phase III Trial of the HIT-HGG Study Group for the Treatment of High Grade Glioma, Diffuse Intrinsic Pontine Glioma, and Gliomatosis Cerebri in Children and Adolescents < 18 Years.(HIT-HGG-2013)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Göttingen
Collaborators
Deutsche Kinderkrebsstiftung, Hannover Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The HIT-HGG-2013 trial offers an innovative high-quality diagnostics and science program for children and adolescents >3 years, suffering from one of the following types of high grade gliomas: glioblastoma WHO grade IV (GBM) diffuse midlineglioma histone 3 K27M mutated WHO grade IV (DMG) anaplastic astrocytoma WHO grade III (AA) diffuse intrinsic pontine glioma (DIPG) gliomatosis cerebri (GC) For 1.-3. diagnosis has to be confirmed by neuropathological survey, for 4. and 5. diagnosis has to be confirmed by neuroradiological survey. In addition to standard treatment (radiotherapy and temozolomide chemotherapy) the effect of valproic acid which is traditionally used for treatment of seizure disorder, will be investigated. The aim of the trial will be to investigate whether this drug may increase the effects of radio- and chemotherapy, resulting in a better survival of the treated patients. Scientific studies provided evidence for anti-tumoral effects of valproic acid: the drug seems to be a so-called histondeacetylase inhibitor (HDAC inhibitor), controlling important genetic processes of tumor growth. Studies in cell culture, animals and first clinical trials in adults as well provided evidence for efficacy of valproic acid in the treatment of glioblastoma. Due to this we hope children and adolescents suffering from GBM, DMG, AA, DIPG und GC will benefit from the treatment, too. The aim of the HIT-HGG-2013 trial will be to compare the effects of Valproic acid with data of the HIT-HGG-2007 trial (children and adolescents with same diseases, only treated with simultaneous temozolomide radiochemotherapy). In the present study, it was originally planned to investigate the therapeutic efficiency and safety of valproic acid and the autophagy inhibitor chloroquine, both in addition to temozolomide therapy. Since distribution of Resochin junior (chloroquine phosphate) was terminated, recruitment of new patients was stopped on August 8, 2019. For continuation of the trial, the chloroquine arm was closed but the patients already recruited in this arm will be followed up.
Detailed Description
Indication: First-line treatment of high grade gliomas, diffuse intrinsic pontine glioma, and gliomatosis cerebri in paediatric patients < 18 years of age. Background: Based on published preclinical and clinical results regarding the potential therapeutic benefit of adult and pediatric high grade glioma patients receiving the histone deacetylase (HDAC) inhibitor valproic acid (VPA; Barker et al. 2013; Wolff et al. 2008, 2011; Felix et al. 2011; Su et al. 2011; Rokes et al. 2010; Masoudi et al. 2008; Guthrie et al. 2013; Weller et al. 2011) in addition to radiochemotherapy, the present trial is aimed to investigate if the addition of VPA to radiochemo- and maintenance therapy with temozolomide (Stupp et al. 2005; Cohen et al. 2011a, b) provides a survival advantage in comparison to radiochemo- and maintenance therapy with temozolomide alone. Therapeutic efficiency of VPA will be evaluated by comparison with a historical patient control from the previous trial HIT-HGG-2007 with temozolomide radiochemo- and maintenance therapy alone. Besides therapeutic efficiencies as indicated by event-free survival (EFS) and overall survival (OS) treatment-related toxicities will also be analysed. Therapy: TMZ and VPA will be studied as investigational medicinal products in the present trial. Trial treatment will be performed as follows: Surgery with best possible extent of tumour resection Start as soon as diagnosis is confirmed with VPA 10 mg/kg/d in two daily doses preferencially as NONRETARDED FORMULA (e.g. Valproat-neuraxpharm®, Valproat-neuraxpharm® Lösung, Ergenyl®, Ergenyl®-Lösung or Orfiril® Saft; however, any VPA preparation including generic drugs is allowed; the use of a retarded formula might be helpful in some case as indicated below), increase by 10 mg/kg/d once per week up until recommended target Serum level of 75-100 μg/ml (520-694 μmol/L) is reached. If target serum levels cannot be reached with non-retarded formula and/or side effects occur which might be connected to VPA, change to a retarded formula may be helpful to obtain sufficient VPA serum levels and/or reduce side effects. If VPA target serum levels are still not reached and/or side effects occur even with a retarded VPA formula, please contact the HIT-HGG study office. After start of VPA induction with simultaneous radiochemotherapy: Fractionated, locoregional radiotherapy, total dose 54-60 Gy Simultaneous chemotherapy with oral temozolomide, 7 days per week at 75 mg/m2/d, starting at day 1 for the entire period of radiotherapy (at maximum 49 days; oral temozolomide treatment may be started in single cases at maximum 7 days before radiotherapy if the 49 days treatment period still fully covers radiotherapy). Please, use temozolomide capsules (for oral application) and temozolomide powder (for preparation of an intravenously applicable solution). Any temozolomide preparation including generic drugs is allowed except for patients who are not able to swallow capsules and in whom the use of an intravenous solution is no Option only Temodal® capsules must be used to generate a temozolomide suspension as described in the Appendix A.11. Parents have to be advised how to prepare the Temodal® suspension at the trial site. PLEASE NOTE: Capsules of generic temozolomide drugs other than Temodal® MUST NOT be opened and used for generating temozolomide suspension. Maintenance therapy with daily VPA and temozolomide four weeks after simultaneous radiochemotherapy initiation of a 5 day-course of oral temozolomide [150-200 mg/m2/d], repeated every 28 days for in total 12 courses VPA treatment is performed until day 28 of the 12th course of temozolomide. Treatment doses may vary according to available medication formulations and sizes. Thus, deviances of +/- 15% of the recommended doses may be acceptable if not stated otherwise.The starting points of treatment may also vary in single cases. Thus, deviances of +/- 7 days of the recommended time periods to start treatment may be acceptable if not stated otherwise. Primary end point : Event-free survival Biometry (regarding the primary objectives): Confirmatory statistical design: 1. Difference between the treatment with additional VPA and the historic sample from the HIT-HGG-2007 study with respect to EFS. Rejection of H0 will be interpreted as a significant difference between VPA treatment and the historic sample. A directional interpretation will detect either a superiority of the VPA-treatment compared to the historic sample, or a superiority of the historic sample compared to the VPA Treatment sample. Statistical tests: adaptive Log-rank test / (conventional) Log-rank test Multiple Significance level α(overall) = 5% Power = 80% Assumed 6 months EFS-rates = 55% vs. 70% Multiple Testing: No Multiplicity Problem in this trial. Estimated sample sizes: About 167 recruitments at final analysis Patient recruitment will be performed for 5,4 years. Individual follow-up (including study treatment) is required for this protocol for at least 1 year and 30 days after study entry. Long-term follow-up is strongly recommended and will be organised according to national guidelines and recommendations. Financial support: Deutsche Kinderkrebsstiftung, Bonn, Germany

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma WHO Grade IV, Diffuse Midline Glioma Histone 3 K27M WHO Grade IV, Anaplastic Astrocytoma WHO Grade III, Diffuse Intrinsic Pontine Glioma, Gliomatosis Cerebri
Keywords
Glioblastoma, high grade glioma, brain tumor, Anaplastic astrocytoma, DIPG, Gliomatosis cerebri, Diffuse midline glioma, Valproic acid, Temozolomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Temozolomide + Valproic acid
Arm Type
Experimental
Arm Description
E.g. Valproat-neuraxpharm®, Valproat-neuraxpharm® Lösung, Ergenyl®, Ergenyl®-Lösung oder Orfiril® Saft (Valproic acid), [10 mg/kg/d] tablet oder juice, p.o., every day in parallel to simultaneous radiochemotherapy with cytostatic drug Temodal (Temozolomid): [75 mg/m2/d] during simultaneous radiochemotherapy (7 days a week, max. 49 days); [150-200 mg/m2/d] during consolidation therapy (for 5 days every 28 days, 12 cycles), tablets, p.o. (or powder for preparation of an intravenously applicable solution).
Intervention Type
Drug
Intervention Name(s)
Temozolomide + Valproic Acid
Intervention Description
Valproic acid additionally to simultaneous radiochemotherapy with temozolomide
Primary Outcome Measure Information:
Title
Comparison of effects of valproine acid with respect to historical control group.
Description
To confirm that the Event-Free Survival (EFS) in patients ≥ 3 years of age with paed HGG WHO grade IV, anaplastic astrocytoma WHO grade III (AAIII), DIPG, and gliomatosis cerebri differs for children treated with additional VPA compared to children in the historical HIT-HGG-2007 study sample.
Time Frame
5.4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed, previously untreated diffuse paediatric high grade glioma with central neuropathological review including paedHGG (WHO grade IV) and anaplastic astrocytoma (WHO grade III). Newly diagnosed, previously untreated diffuse intrinsic pontine glioma with central neuroradiological review Newly diagnosed, previously untreated gliomatosis cerebri of all tumour grades with central neuroradiological review Patient ≥ 3 years and < 18 years of age at time of diagnosis Written informed consent of the patient and/or the patient's parents or legal guardian according to national laws Exclusion Criteria: Pre-treatment of paedHGG (WHO grade IV), anaplastic astrocytoma (WHO grade III), diffuse intrinsic pontine glioma (as confirmed by neuroradiological review), and gliomatosis cerebri (as confirmed by neuroradiological review). Known hypersensitivity or contraindication to study drugs and/or dacarbazine Prior chemotherapy within the last 30 days before HIT-HGG-2013 treatment or radiotherapy which prevents adequate Performance of radiotherapy as outlined by the present protocol. This may mainly apply to patients with secondary high grade glioma after previous malignant brain tumour, e.g. medulloblastoma, ependymoma, craniopharyngeoma. If previous treatment does not prevent the adequate performance of the outlined Treatment protocol patients with secondary high grade glioma will be eligible for the present trial. Other (simultaneous) malignancies Pregnancy and / or lactation Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly) Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial. Clinical (e.g. a constitutional mismatch repair deficiency score ≥ 3; Wimmer et al. 2014) and/or other hints (e.g. absent intratumoral immunohistochemical expression of at least one of the MLH1, MSH2, MSH6, or PMS2 mismatch repair proteins and/or high microsatellite instability) for an underlying biallelic (constitutional) mismatch repair deficiency (bMMRD/CMMRD) or a heterozygous mismatch repair deficiency (hereditary non-polyposis colon cancer syndrome/HNPCC syndrome/Lynch syndrome): These patients and their relatives should be offered human genetic counseling and rapid genetic diagnostics to confirm or rule out These conditions. These patients might not benefit from the present study treatment but maybe from other therapeutic strategies (Bouffet et al. 2016). Since patients with clinically suspected neurofibromatosis type 1 may display similar symptoms as in CMMRD, patients with clinically suspected neurofibromatosis type 1 should be also checked for CMMRD as suggested above. Very poor clinical condition as defined by demand of mechanical ventilation and/or demand for intravenous catecholamines and/or very severe neurological damage equivalent to a coma and/or tetraplegia with complete incapability for communication (deafness, blindness, mutism) Severe concomitant diseases (e.g. immune deficiency syndrome; known tumour predisposition syndromes which do not affect adequate performance of the trial represent no exclusion criterion a priori Known HIV positivity Known severe manifest hepatic disease including hepatic porphyria as well as personal or family history of severe hepatic dysfunction, especially drug-related Known severe pancreatic disease Known lethal hepatic dysfunction in a sibling during valproic acid treatment Known urea cycle defect Known mitochondrial diseases caused by genetic mutations within the gene coding for the enzyme polymerase gamma (POLG), e.g. Alpers-Huttenlocher syndrome, as well as suspected POLGrelated disorders in children under the age of two years Known severe coagulation disorders (in regards to thrombopenia see prerequisite for blood cell count before starting treatment) Valproic acid as antiepileptc drug for any pre-existing epilepsy (Exception: Valproic acid treatment due to tumour-related epilepsy will be tolerated, if the time interval between start of valproic acid treatment and trial enrolment is ≤ 8 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christof Kramm, Prof., MD
Phone
49(0)551 39 63081
Email
christof.kramm@med.uni-goettingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christof Kramm, Prof., MD
Organizational Affiliation
University of Göttingen
Official's Role
Study Chair
Facility Information:
Facility Name
Universitätsklinik RWTH Aachen
City
Aachen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udo Kontny, Prof. Dr.
Facility Name
Klinikum Augsburg
City
Augsburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Frühwald, Prof.
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Hernaiz-Driever, PD Dr.
Facility Name
HELIOS Klinikum Berlin Buch
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Hundsdörfer, PD Dr.
Facility Name
Evangelisches Krankenhaus Bielefeld
City
Bielefeld
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Jorch, Dr.
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Calaminus, Dr.
Facility Name
Städtisches Klinikum Braunschweig gGmbH
City
Braunschweig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Torsten Ebeling, Dr.
Facility Name
Klinikum Bremen-Mitte gGmbH
City
Bremen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnulf Pekrun, Prof.
Facility Name
Carl-Thiem-Klinikum Cottbus gGmbH
City
Cottbus
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Schwabe, PD Dr.
Facility Name
Klinikum Dortmund gGmbH
City
Dortmund
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Schneider, Prof. Dr.
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Knöfler, Prof. Dr.
Facility Name
Sana Kliniken Duisburg GmbH - Wedau Kliniken
City
Duisburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanja Höll, Dr.
Facility Name
HELIOS Klinikum Erfurt GmbH
City
Erfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Sauerbrey, Prof. Dr.
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markus Metzler, Prof.
Facility Name
Universitätsklinikum Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Regina Wieland, Dr.
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martina Becker, Dr.
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Niemeyer, Prof.
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Mauz-Körholz, Prof. Dr.
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Lode, Prof.
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christof Kramm, Prof.
Facility Name
Universitätsklinikum Halle
City
Halle
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toralf Bernig, Dr.
Facility Name
Universitätsklinikum Hamburg
City
Hamburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uwe Kordes, Dr.
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Sander, Dr.
Facility Name
Angelika-Lautenschläger-Klinik
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olaf Witt, Prof. Dr.
Facility Name
SLK-Kliniken Heilbronn GmbH
City
Heilbronn
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Streiter
Facility Name
Gemeinschaftskrankenhaus Herdecke
City
Herdecke
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Längler, Prof. Dr.
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Graf, Prof.
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd Gruhn, Prof. Dr.
Facility Name
Städtisches Klinikum Karlsruhe
City
Karlsruhe
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Leipold, Dr.
Facility Name
Gesundheit Nordhessen - Klinikum Kassel
City
Kassel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaela Nathrath, Prof.
Facility Name
UKSH Kiel
City
Kiel
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Claviez, PD Dr.
Facility Name
Gemeinschaftsklinikum Mittelrhein gGmbH
City
Koblenz
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ümmügül Behr, Dr.
Facility Name
HELIOS Klinikum Krefeld
City
Krefeld
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Imschweiler
Facility Name
Kliniken der Stadt Köln gGmbH
City
Köln
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Balzer, Dr.
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Fischer, Dr.
Facility Name
UKSH Campus Lübeck
City
Lübeck
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Langer, Prof. Dr.
Facility Name
Universitätsklinikum Magdeburg A. ö. R.
City
Magdeburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antje Redlich, Dr.
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jörg Faber, Prof. Dr.
Facility Name
UMM Universitätsmedizin Mannheim
City
Mannheim
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Dürken, PD Dr.
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Erdlenbruch, Prof.
Facility Name
Technische Universität München / Klinikum Schwabing
City
München
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Teichert-von-Lüttichau, PD Dr.
Facility Name
Universitätsklinikum Münster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Sträter, PD Dr.
Facility Name
Klinikum Oldenburg gGmbH
City
Oldenburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Müller, Prof.
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Jakob, Dr.
Facility Name
Universitäts-Kinder- und Jugendklinik Rostock
City
Rostock
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
ASKLEPIOS Klinik St. Augustin
City
Sankt Augustin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harald Reinhard, PD Dr.
Facility Name
HELIOS Kliniken Schwerin GmbH
City
Schwerin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aram Prokop, Dr. Dr.
Facility Name
Klinikum Stuttgart - Olgahospital
City
Stuttgart
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Blattmann, PD Dr.
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Ebinger, PD Dr.
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klaus-Michael Debatin, Prof. Dr.
Facility Name
Universitätsklinik Würzburg
City
Würzburg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Eyrich, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)

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