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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma

Study:

A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

Rationale:

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.

Purpose:

This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.

Study Status: Recruiting

Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100

Condition Intervention Phase
Brain Tumor
Central Nervous System Tumor
Drug: cisplatin
Drug: cyclophosphamide
Drug: lomustine
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 3

Verified by Children`s Oncology Group June, 2013

Sponsored by: Children`s Oncology Group
Information provided by: Children`s Oncology Group
ClinicalTrials.gov identifier: NCT00085735

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Jeff M. Michalski, MD., Study Chair

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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