HIT 2000

Author: Prof. Dr. med. Stefan Rutkowski, erstellt 2003/07/24, Last modification: 2015/02/16

HIT 2000 Multicenter therapy optimising trial for the treatment of children and adolescents with medulloblastoma, intracranial primitive neuroectodermal tumours of the central nervous system (CNS-PNET), and ependymoma
Disease CNS Tumours (Medulloblastoma, Ependymoma, supratentorial CNS-PNET)
Type Prospective phase-III multicenter trial
Problem / Objectives

It is the aim of this multicenter therapy optimising trial HIT 2000 to offer all patients up to an age of 21 years with a intracranial localized Medulloblastoma / supratentorial CNS-PNET or Ependymoma the today best known risk-adapted standard therapy in Germany and Austria.

Primary objectives are the achievement of a comparable high survival rate of the patients through intensification of the chemotherapy and / or irradiation, through risk adapted therapy in exact defined risk-groups and through better quality control of surgery,
radiotherapy and chemotherapy.
Further objective is a comparable low rate of late effects through the abandonment of the irradiation or reduction of the cranio-spinal irradiation dose with children younger than 4 years with a Medulloblastoma.

For the acquisition of data to late effects and quality of life different concomitant studies are performed.

Objectives of the interim registry

The main objective of the registry until the opening of the new trials is the quality assurence through reference expertise of the different examinations and to collect epidemiological data.
In addition the collection of biological material (tumourtissue, cerebral fluid and blood) shall be continued to assure the continuation of concomittant studies. Therefore therapy data should be furthermore collected.

Therapy / Study arms

To reach the best and most individual therapy for every patient, concerning the risk of relapse and late effects, the therapy will be stratified regarding histology (Medulloblastoma, supratentorial CNS-PNET, Ependymoma WHO II° and Ependynoma WHO III°), age (4 years) and stage of the disease (MO versus M1 versus M2-M4) into 10 relevant therapy groups.

In the prospective randomised phase-III trial for patients from 4-21 years with local Medulloblastoma, conventional radiation therapy will be compared to hyperfractionated radiation therapy. The aims of this randomized trial were to compare progression-free survival and late effects after the two different radiation schedules. Recrutation into the experimental arm was closed on 31.12.2006

For children with local supratentorial CNS-PNET an amendment was published in 2004.

Therapy recommandations after the closure of the trial

In the appendix of the registry the therapy recommandations are enclosed. They result of the evaluated therapy concepts of HIT 2000.
In some therapy arms the therapy follows the amendments. In some therapy arms, where the amandments brought no advantage, the therapy will follow the original concept. Theses rcommandations were decided after the the last interim analysis of HIT 2000 and are not obligatory.

Inclusion Criteria
  • Medulloblastoma and Medulloblastoma-Variations (desmoplastic Medulloblastoma, anaplastic Medulloblastoma, large-cell Medulloblastoma, Medullomyoblastoma, melanotic Medulloblastoma)
  • supratentorial CNS-PNET (primitive neuroectodermal Tumour)
  • Ependymoblastoma
  • Pineoblastoma
  • cerebral Neuroblastoma
  • Ependymoma WHO II° and WHO III°
  • intracranial Sarkoma
  • Medulloepithelioma
  • spinal PNET (primitive neuroectodermal Tumours)
  • spinal Ependymoma WHO II° and III°
Status since 01.01.2001
Principal Investigator Prof. Dr. med. Stefan Rutkowski
E-Mail hitchem@uke.uni-hamburg.de
Contact

Principal Investigator

Prof. Dr. med. Stefan Rutkowski Universitätsklinikum Hamburg-Eppendorf Klinik u. Poliklinik f. Päd. Onkologie u. Hämatologie, Haus N21 Martinistr. 52 20246 Hamburg Telefon +49 (40) 7410 58200 Fax +49 (40) 7410 58300 s.rutkowski@uke.de

Study Coordination

Dr. med. Katja von Hoff Universitätsklinikum Hamburg-Eppendorf Klinik für Pädiatrische Hämatologie und Onkologie Martinistr. 52 20246 Hamburg Telefon +49 (40) 7410-53394 Fax +49 (40) 7410 58300 k.von-hoff@uke.de

Study Coordination

Documentation

Chairperson Austria

Reference center Radiology

Reference center spinal fluid

Reference center Neuroradilogy

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

Neuro-psychological concomittant study

Weitere Informationen The results of the first interim-analysis of this trial were satisfactory. For children with the diagnosis of a supratentorial CNS-PNET without metastasis an amendment for the traetment was made at the end of 2004.
Link(s) Literature on Medulloblastoma, supratentorial CNS-PNET, Ependymoma
Sponsoring The HIT 2000 trial and the reference institutions are supported by "Deutsche Kinderkrebsstiftung". The trial is certified with the "Gütesiegel A "of the "Deutschen Krebsgesellschaft".