Phase II Study Evaluating Proton Beam Radiation Therapy for Neuroblastoma and Ganglioneuroblastoma in Children and Young Adults

What this Trial Is About

Researchers are evaluating proton beam radiation therapy PBRT as a possible treatment for neuroblastoma, a cancer that usually develops in and around the adrenal glands but can also occur in other nerve cell areas like the abdomen, neck, and near the spine. This study aims to compare proton radiation with standard photon radiation, focusing on reducing side effects and assessing late complications after treatment. The trial is sponsored by Massachusetts General Hospital and targets pediatric and young adult patients with neuroblastoma or ganglioneuroblastoma. Proton radiation therapy is given daily from Monday to Friday for 3 to 4 weeks, with each session lasting 30 to 45 minutes while the participant lies on a treatment table. The therapy is outpatient and delivered at Massachusetts General Hospital. Weekly during treatment, participants will have physical exams, side effect assessments, and routine blood tests. After completing radiation, participants return for follow-up visits 3 to 6 months later and then annually for up to 5 years, which include medical history reviews, physical exams, imaging, side effect checks, and lung and heart function tests if needed. Participants will be closely monitored throughout the study for both immediate and long-term side effects, with regular assessments during and after treatment. The main outcomes measured include the occurrence of late radiation complications and acute toxicities over 5 years, along with progression-free and overall survival rates tracked up to 10 years. This long-term follow-up helps researchers understand the safety and effects of proton therapy compared to conventional radiation.

Phase II Study of Proton Radiation Therapy for Neuroblastoma