Research

Medulloblastoma Chemotherapy with Reduced Craniospinal and Boost-dose Radiotherapy – Phase III

Evaluation of Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

Protocol Description

This Children’s Oncology Group Phase III trial will compare two treatments for a medulloblastoma located in the back of the brain (posterior fossa) following surgery. Specifically, the study will compare chemotherapy plus standard-dose radiation to a regimen that combines chemotherapy with reduced-dose craniospinal radiation therapy and reduced boost radiation therapy to the tumor site. Researchers hope to determine if the overall dose of radiation to the brain and spine can be reduced without impairing outcomes in children with medulloblastoma

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to individuals of both genders, from age 3 to 21, who have been diagnosed with standard-risk medulloblastoma, a tumor located in the back of the brain, which has been removed through surgery and has not spread to other parts of the body.
Males: Ages 3 to 21 years
Females: Ages 3 to 21 years

Requirements
Participants will be randomly assigned into treatment groups. Treatment begins about 4 weeks after surgery and consists of two cycles. Cycle A, which repeats once, lasts for 6 weeks and includes radiation therapy 5 days a week with intravenous chemotherapy once a week. Cycle B lasts 4 weeks, with chemotherapy provided on days 1, 2 and 8.
Frequency of visits: 5 days a week for both A cycles and less frequently for Cycle B
Duration: Approximately 16 weeks, with participants followed for about 4 years

Status: Open for Enrollment

Source(s) of Support
Children’s Oncology Group (Study ACNS0331)
National Cancer Institute
Third Party

Additional Resources
Study Description at National Institutes of Health