This phase II trial studies the side effects and how well proton beam radiation therapy works in treating patients with neuroblastoma or ganglioneuroblastoma. Proton beam radiation therapy delivers radiation directly to the tumor and may kill more tumor cells while causing less damage to normal tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02112617.
PRIMARY OBJECTIVES:
I. To describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma; specifically, cardiac, pulmonary, gastrointestinal, endocrine, growth and second malignancies will be described.
II. To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma; specifically, nausea, vomiting, diarrhea, radiation pneumonitis and skin toxicity will be described.
SECONDARY OBJECTIVE:
I. To determine the progression free survival and overall survival rates of patients with neuroblastoma treated with proton radiation.
OUTLINE:
Patients undergo proton beam radiation therapy once daily (QD) 5 days a week for 3-4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 3-6 months and then annually thereafter.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorKevin Xinye Liu