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Radiation Therapy and Combination Chemotherapy in Treating Young Patients With Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Ependymoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303810
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : January 28, 2014
Information provided by:
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy in different ways and giving it together with more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which radiation therapy and combination chemotherapy regimen is more effective in treating medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), or ependymoma.

PURPOSE: This clinical trial is studying six different radiation therapy and combination chemotherapy regimens to compare how well they work in treating young patients with medulloblastoma, PNET, or ependymoma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide phosphate Drug: high-dose chemotherapy Drug: lomustine Drug: methotrexate Drug: thiotepa Drug: vincristine sulfate Radiation: radiation therapy Not Applicable

Detailed Description:


  • Compare prognosis, using adapted risk stratification and quality control of diagnostic assessments and therapy, in pediatric patients with intracranial medulloblastoma, supratentorial primitive neuroectodermal tumor (PNET), or ependymoma treated with intensified chemotherapy and radiotherapy.
  • Determine the effect of omission of radiotherapy, in terms of long-term sequelae, in young children with medulloblastoma and by hyperfractionation and reduction of radiotherapy in older children with medulloblastoma.
  • Compare hyperfractionated radiotherapy with reduced-dose radiotherapy in older children with stage M0 medulloblastoma.

OUTLINE: This is a multi-protocol study. Patients are enrolled on 1 of 6 treatment protocols according to diagnosis and age at diagnosis.

  • Protocol HIT-2000-AB4 (≥ 4 years old at diagnosis with nonmetastatic medulloblastoma)(phase III randomized controlled multicenter study): Patients are randomized to undergo hyperfractionated radiotherapy or conventional reduced-dose radiotherapy, followed by vincristine, lomustine, and cisplatin.
  • Protocol HIT-2000-BIS4 (< 4 years old at diagnosis with nonmetastatic medulloblastoma): Patients receive 5 courses of cyclophosphamide, vincristine, methotrexate, carboplatin, etoposide phosphate, and intrathecal methotrexate. Patients with residual tumors after 3 courses undergo conventionally fractionated reduced-dose radiotherapy.
  • Protocol MET-HIT-2000-AB4 (≥ 4 years old at diagnosis with metastatic medulloblastoma or supratentorial PNET): Patients receive combination chemotherapy as in HIT-2000-BIS4 for 2 courses. Patients then undergo hyperfractionated radiotherapy and receive combination chemotherapy as in HIT-2000-AB4. Patients with good response to combination chemotherapy (as in HIT-2000-BIS4) also receive high-dose chemotherapy.
  • Protocol MET-HIT-2000-BIS4 (< 4 years old at diagnosis with metastatic medulloblastoma or supratentorial PNET): Patients receive 2-4 courses of carboplatin IV and etoposide phosphate IV continuously over 96 hours. Patients with partial or complete response also receive high-dose carboplatin, etoposide phosphate, cyclophosphamide, and thiotepa. Patients with residual tumor undergo conventional fractionated, reduced-dose radiotherapy.
  • Protocol E-HIT-2000-AB4 (≥ 4 years old at diagnosis with intracranial ependymoma): Patients undergo local hyperfractionated radiotherapy. If histological grading shows WHO grade III tumor, patients also receive 5 courses of vincristine, cyclophosphamide, carboplatin, and etoposide phosphate.
  • Protocol E-HIT-2000-BIS4 (< 4 years old at diagnosis with intracranial ependymoma): Patients receive 5 courses of cyclophosphamide, vincristine, methotrexate IV, carboplatin, and etoposide phosphate and then undergo conventional fractionated local radiotherapy.

PROJECTED ACCRUAL: A total of 567 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 567 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Therapy Optimizing Study for Treatment of Children and Adolescents With Intracranial Medulloblastoma / PNET and Ependymoma
Study Start Date : January 2001
Actual Primary Completion Date : December 2013

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed diagnosis of 1 of the following:

    • Medulloblastoma
    • Supratentorial primitive neuroectodermal tumor (PNET)
    • Ependymoma
  • Intracranial tumor

    • No brain stem tumors
  • No recurrent or relapsed tumors


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303810

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University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Study Chair: Stefan Rutkowski, MD University Med. Center Hamburg, Dpt. of Pediatric Hematology and Oncology
OverallOfficial: Frank Deinlein, MD Universitaets - Kinderklinik Wuerzburg
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Layout table for additonal information Identifier: NCT00303810    
Other Study ID Numbers: CDR0000455572
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: July 2009
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
childhood infratentorial ependymoma
childhood supratentorial ependymoma
untreated childhood medulloblastoma
newly diagnosed childhood ependymoma
untreated childhood supratentorial primitive neuroectodermal tumor
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action