• 
• 

Since March 2009, the Department of Pediatric Hematology and Oncology at the University Medical Center Hamburg-Eppendorf (UKE) has hosted the HIT-MED Study Center. Coordinated by Prof. Dr. Stefan Rutkowski, the multidisciplinary team includes physicians, clinical trial managers, data managers and psychologists.

As part of the HIT-MED group, our team coordinates and oversees national and European clinical studies focused on therapy optimization for children and adolescents with medulloblastoma, ependymoma, pineal region tumors, and choroid plexus tumors. In addition, the center conducts accompanying research addressing key questions in tumor biology and the long-term effects of therapy.

The Study Center also manages the I-HIT-MED Registry, an international registry (Germany, Austria, Switzerland) for patients with a primary diagnosis or experiencing a relapse of one of the aforementioned tumor types. The data management team supports participating centers across Germany and ensures high-quality data collection from patients and entry into study-specific databases.

The Study Center organizes regular clinical consultations and tumor-specific virtual tumor boards, which take place twice a week. Registration for the tumor boards is carried out by the treating physicians.

In addition to improving survival rates, the study center places particular emphasis on therapy-related quality of life. Our team of psychologists systematically assesses neurocognition and quality of life in survivors to integrate these findings into the HIT-MED studies.

Contact

Please note that the HIT-MED Study Center cannot provide medical advice to patients or their families.

We kindly ask patients and families to contact their treating physicians or the responsible treatment center on site for any personal medical questions or concerns.

Address of the HIT-MED Study Center:
Universitätsklinikum Hamburg-Eppendorf
Klinik für Pädiatrische Hämatologie und Onkologie
HIT-MED Studienzentrale
Martinistraße 52
20246 Hamburg

Lead coordinator:
Prof. Dr. med. Stefan Rutkowski
Email: s.rutkowski@uke.de
Tel.: +49 (0) 40 7410 - 54270

Deputy coordinator:
PD Dr. med. Martin Mynarek
Email: m.mynarek@uke.de
Tel.: +49 (0) 40 7410 - 53394

Study Physicians:
Dr. med. Denise Obrecht-Sturm
Email: d.obrecht-sturm@uke.de
Tel.: +49 (0) 40 7410 - 52741

Mina Langhein
Email: mi.langhein@uke.de
Tel.: +49 (0) 40 7410 - 52741

Dr. med. Marthe Sönksen
Email: ma.soenksen@uke.de
Tel.: +49 (0) 40 7410 - 52741

Study Management:
Regine Riechers
Email: r.riechers@uke.de
Tel.: +49 (0) 40 7410 - 56776
Fax: +49 (0) 40 7410 - 58300

Aran Abengochea Molar
Email: a.abengocheamolar@uke.de
Tel.: +49 (0) 40 7410 - 53394
Fax: +49 (0) 40 7410 - 58300

Documentation:
Susanne Becker und Antje Stiegmann
Email: hitchem@uke.de
Tel.: +49 (0) 40 7410 - 58200
Fax: +49 (0) 40 7410 - 58300

Neuropsychologists:
Anne Rossius, M. Sc. Psychologie
Email: a.rossius@uke.de , hitmed-neuropsychologie@uke.de
Tel.: +49 (0) 40 7410 - 54572
Fax: +49 (0) 40 7410 - 58300

Dr. Lisa Bußenius, Psychologin
Email: l.bussenius@uke.de , hitmed-neuropsychologie@uke.de
Tel.: +49 (0) 40 7410 - 54572
Fax: +49 (0) 40 7410 - 58300

The HIT-MED Group, through the HIT-MED Study Center, operates an international registry for all patients within the HIT Network (Germany, Austria, Switzerland) who are newly diagnosed with or experience a relapse of the following tumor entities:

• Medulloblastoma
• Ependymoma
• Pineal region Tumors
• Choroid Plexus Tumors

The goal is to collect clinical information and biological tumor material for research purposes in order to gain deeper insights into tumor biology and clinical progression even outside of controlled clinical trials. In addition, the resulting database is intended to support diagnostic and therapeutic decisions for rare tumors or unusual treatment constellations, including the identification of patients eligible for prospective clinical trials.

The I-HIT-MED registry is funded by the German Childhood Cancer Foundation (www.kinderkrebsstiftung.de).

ClinicalTrials.gov ID: NCT02417324

SIOP Ependymoma II is a multicenter Phase II/III clinical trial investigating treatment strategies for children and adolescents with ependymoma who are 21 years of age or younger at the time of diagnosis.

The international study is led by Dr. Pierre Leblond at the Centre Léon Bérard in Lyon, France. In Germany, the trial is coordinated nationally by Prof. Dr. med. Stefan Rutkowski in Hamburg.

Patients are stratified into different treatment arms based on age, tumor location, and the outcome of initial tumor resection. Each stratum has distinct research objectives:

Stratum 1:

• Can maintenance chemotherapy following standard radiotherapy reduce the risk of relapse in patients older than 12 months and with a complete tumor resection?

Stratum 2:

• Does the addition of high-dose methotrexate (MTX) to VEC chemotherapy provide a therapeutic advantage for patients with residual tumor?
• For patients with inoperable residual tumor after therapy, can a radiation “boost” to the remaining tumor improve local tumor control?
• What impact does this radiation boost have on survival outcomes and quality of life?

Stratum 3:

• Can the addition of valproate to chemotherapy alone reduce relapse risk in children under 12 months of age?

All strata:
Furthermore, many secondary questions are to be addressed, including the impact of a mandatory neurosurgical second opinion, late effects of the disease and its therapy, and aspects of tumor biology.

In Germany, the SIOP Ependymoma II study is funded by the German Childhood Cancer Foundation ( www.kinderkrebsstiftung.de ).

EU CT Nr. 2024-512222-28-00 (EudraCT Nr. 2013-002766-39)

ClinicalTrials.gov ID: NCT02265770

SIOP HRMB is a multicenter Phase III clinical trial investigating treatment strategies for children and adolescents with high-risk medulloblastoma who are older than 3 years at the time of diagnosis.

The international coordination of the study is led by Prof. Simon Bailey from the Sir James Spence Institute of Child Health in Newcastle upon Tyne, United Kingdom. In Germany, the study national coordinator is Prof. Dr. Stefan Rutkowski in Hamburg.

The trial focuses on two primary research questions:

• Can survival in children with high-risk medulloblastoma be improved by one of the following treatment approaches compared to standard therapy (once-daily, so-called “normo-fractionated” radiotherapy)?
  • Twice-daily, “hyperfractionated accelerated” radiotherapy (HART)
  • High-dose chemotherapy with thiotepa followed by standard radiotherapy

• Does the type of maintenance chemotherapy administered after radiotherapy influence survival in children with high-risk medulloblastoma?

In addition, the study addresses multiple secondary objectives, including the investigation of late effects of the disease and its treatment, as well as insights into tumor biology.

The SIOP HRMB study in Germany is funded by the German Childhood Cancer Foundation ( www.kinderkrebsstiftung.de ).

EU CT Nr. 2024-510578-25 (EudraCT Nr. 2018-004250-17)

ISRCTN Nr. 16314648

COGNITO-MB is a prospective, trans-atlantic Phase III clinical trial aimed at improving neurocognitive outcomes in young children diagnosed with low-risk medulloblastoma before the age of five.

The study is led by Prof. Dr. Stefan Rutkowski at the University Medical Center Hamburg-Eppendorf (UKE) in Europe, and co-led by Prof. Dr. Girish Dhall of the CONNECT consortium in North America. The study has been submitted to the German authorities and is expected to begin recruiting in early 2026.

The aim of the COGNITO-MB study is to compare two well-established and effective treatment strategies (HIT-SKK and Head Start 4) in this age group, with a novel focus on neurocognitive outcomes as the primary goal of the study. This is the first randomized trial ever conducted in this patient population and the first to use standardized neuropsychological testing as the primary objective. By evaluating the long-term cognitive and quality-of-life effects of these treatments, the trial aims to determine which approach best preserves brain development in these very young children.

The study also includes comprehensive clinical and biological evaluations to better understand late treatment effects and to guide follow-up care after therapy.

COGNITO-MB is sponsored by the German Society for Pediatric Oncology and Hematology ( GPOH ) and funded by the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) in Germany.

EU-CT Nr: 2024-517133-40-00

Patient recruitment for the SIOP PNET5 MB study ended on April 6, 2022, and no further patients can be enrolled.

The study is led by Prof. Rutkowski in Hamburg, who is also responsible for the evaluation of the SR arm. Additional principal investigators include Prof. François Doz from the Institut Curie in Paris, France (LR arm and WNT HR arm), and Prof. Till Milde from the University of Jena (SHH TP53 arm).

SIOP PNET5 MB is a multicenter Phase II-III clinical trial for the treatment of children and adolescents with clinically standard-risk medulloblastoma and varying biological risk profiles. Eligible participants were between 3–5 years (depending on risk stratification) and under 22 years of age at diagnosis. A total of 401 patients were enrolled across 13 European countries.

The study focuses on two primary research questions:

• LR (low-risk)-Arm: Is it safe to reduce therapy intensity in patients with a low-risk profile without increasing the risk of relapse?
• SR (standard-risk)-Arm: In patients with so-called “standard-risk” medulloblastoma, can the administration of carboplatin concurrently with radiotherapy improve relapse-free survival compared to radiotherapy alone?

In addition to these primary endpoints, the study explores several secondary questions, including the long-term effects of the disease and its treatment, as well as tumor biology.

Data cleaning and analysis are currently ongoing, and the first publication of results is expected soon.

The UKE has assumed sponsorship of the SIOP PNET 5 MB study, which is funded by the German Childhood Cancer Foundation ( www.kinderkrebsstiftung.de ).

EudraCTNr: 2011-004868-30

ClinicalTrials.gov ID: NCT02066220

HIT2000 was a multicenter therapy optimization study for children, adolescents, and young adults diagnosed with medulloblastoma, ependymoma, or CNS-PNET.

The study was conducted from January 1, 2001, to December 31, 2011, across more than 80 clinics in up to eight European countries. In total, over 1,300 patients were enrolled and treated within one of nine different therapy arms.

HIT2000 (along with its European counterpart PNET4) represented an important step toward building the productive European research structures that are now fundamental to pediatric brain tumor research.

Selection of publications from HIT2000:
Rutkowski S, Gerber NU, von Hoff K, Gnekow A, Bode U, Graf N, et al. Treatment of early childhood medulloblastoma by postoperative chemotherapy and deferred radiotherapy. Neuro Oncol 2009;11(2):201-10.

Lannering B, Rutkowski S, Doz F, Pizer B, Gustafsson G, Navajas A, et al. Hyperfractionated versus conventional radiotherapy followed by chemotherapy in standard-risk medulloblastoma: results from the randomized multicenter HIT-SIOP PNET 4 trial. J Clin Oncol 2012;30(26):3187-93.

Lannering B, Rutkowski S, Doz F. HIT-SIOP PNET-4 - A randomised multicentre study of hyperfractionated (HFRT) versus standard radiotherapy (STRT) in children with standard risk medulloblastoma. Neuro Oncol 2010;12(6):ii5.

Friedrich C, von Bueren AO, von Hoff K, Kwiecien R, Pietsch T, Warmuth-Metz M, et al. Treatment of adult nonmetastatic medulloblastoma patients according to the paediatric HIT 2000 protocol: a prospective observational multicentre study. Eur J Cancer 2013;49(4):893-903.

Friedrich C, von Bueren AO, von Hoff K, Gerber NU, Ottensmeier H, Deinlein F, et al. Treatment of young children with CNS-primitive neuroectodermal tumors/pineoblastomas in the prospective multicenter trial HIT 2000 using different chemotherapy regimens and radiotherapy. Neuro Oncol 2013;15(2):224-34.

Friedrich C, Muller K, von Hoff K, Kwiecien R, Pietsch T, Warmuth-Metz M, et al. Adults with CNS primitive neuroectodermal tumors/pineoblastomas: results of multimodal treatment according to the pediatric HIT 2000 protocol. J Neurooncol 2014;116(3):567-75.