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Sponsored by: |
Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303810 |
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 | Intervention |
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Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide phosphate Drug: lomustine Drug: methotrexate Drug: thiotepa Drug: vincristine sulfate Procedure: high-dose chemotherapy Procedure: radiation therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Multicenter Therapy Optimizing Study for Treatment of Children and Adolescents With Intracranial Medulloblastoma / PNET and Ependymoma |
Estimated Enrollment: | 567 |
Study Start Date: | January 2001 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multi-protocol study. Patients are enrolled on 1 of 6 treatment protocols according to diagnosis and age at diagnosis.
PROJECTED ACCRUAL: A total of 567 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Intracranial tumor
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Germany | |
Universitaets - Kinderklinik Wuerzburg | Recruiting |
Wuerzburg, Germany, D-97080 | |
Contact: Wiebke Treulieb 49-931-2012-7839 |
Study Chair: | Stefan Rutkowski, MD | Universitaets - Kinderklinik Wuerzburg |
Investigator: | Frank Deinlein, MD | Universitaets - Kinderklinik Wuerzburg |
Study ID Numbers: | CDR0000455572, GPOH-HIT-2000, EU-205105 |
Study First Received: | March 15, 2006 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00303810 |
Health Authority: | Unspecified |
childhood infratentorial ependymoma childhood supratentorial ependymoma untreated childhood medulloblastoma newly diagnosed childhood ependymoma untreated childhood supratentorial primitive neuroectodermal tumor |
Neuroectodermal Tumors, Primitive Lomustine Vincristine Carboplatin Central Nervous System Neoplasms Cyclophosphamide Etoposide phosphate Ependymoma Thiotepa Folic Acid |
Neuroectodermal Tumors Cisplatin Neoplasms, Germ Cell and Embryonal Medulloblastoma Neuroepithelioma Methotrexate Glioma Etoposide Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type |
Mitosis Modulators Nervous System Diseases Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |