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 and Central Nervous System Tumors |
Drug: cisplatin Drug: cyclophosphamide Drug: lomustine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
Verified by
Children`s Oncology Group
November, 2012
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00085735
Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Jeff M. Michalski, MD., Study Chair