This pilot clinical trial studies using a lower dose of radiation therapy in treating patients with neuroblastoma that is likely to come back (high-risk) after they have undergone chemotherapy and surgery. Radiation therapy uses high-energy protons to kill tumor cells. After patients undergo chemotherapy and surgery to remove the tumor, radiation therapy is given to help prevent the tumor from coming back. Giving a lower dose of radiation therapy may still reduce the risk that the tumor will return but cause fewer side effects.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02245997.
PRIMARY OBJECTIVE:
I. To assess local control and patterns of failure after a reduction in dose of radiation from 21 Gray (Gy) to 18 Gy to 15 Gy.
SECONDARY OBJECTIVES:
I. To assess rates of event-free survival (EFS) and overall survival (OS) after 15-18 Gy to the primary site.
II. To assess toxicity associated with 15-18 Gy radiation to the primary site.
OUTLINE:
Patients undergo external beam radiation therapy using intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy (RT) twice daily for 5-6 weekdays (10-12 treatments).
After completion of study treatment, patients are followed up every 6 months for 2 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorSuzanne L. Wolden
