NCT02112617

Phase II Study of Proton Radiation Therapy for Neuroblastoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 6 Months – 25 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma. Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine. Conventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy. In this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.

Detailed description

Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes. The radiation therapy will be outpatient at Massachusetts General Hospital. During radiation therapy, the participant will have the following weekly assessments and procedures: * Physical Exam * Assess for any side effects * Routine blood tests (weekly or at least every other week) Post-treatment Follow Up Visit (s): The participant will be asked to return to the clinic 3-6 months after their last dose of radiation therapy and then annually for up to 5 years for the following procedures: * Medical History * Physical Exam * Diagnostic Imaging * Assess for side effects * Lung Function Tests (if required) * MUGA or ECHO (if required)

Conditions

• Neuroblastoma
• Ganglioneuroblastoma

Interventions

Type	Name	Description
RADIATION	Proton Beam Radiation Therapy	Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.

Timeline

• Start date: 2014-06-01
• Primary completion: 2026-06-30
• Completion: 2028-03-01
• First posted: 2014-04-14
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States