Actively Recruiting
Phase II Study of Proton Radiation Therapy for Neuroblastoma
Led by Massachusetts General Hospital · Updated on 2026-05-06
30
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Phase II Study of Proton Radiation Therapy for Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites.
- Pathological review of surgical specimen required if tumor tissue obtained; urinary catecholamine metabolites required if no tissue.
- Participants do not need measurable disease at radiation time.
- Age 3 to 25 years at diagnosis.
- Life expectancy greater than 12 months.
- ECOG performance status 0 to 2 (Karnofsky 60% or Lansky 60%).
- Diagnostic MRI and/or CT within 8 weeks of treatment.
- Baseline bone marrow biopsy and bone scan or MIBG scan from original diagnosis required.
- Women of child-bearing potential and men must agree to use contraception during study.
- Ability and willingness to sign informed consent prior to radiation therapy.
You will not qualify if you...
- Prior therapeutic radiation therapy greater than 500 cGy.
- Chemotherapy completed 1 year or more before planned radiation or referral after relapse following chemotherapy alone.
- History of different malignancy unless disease-free for 5 years or specific skin/cervical cancers treated within 5 years.
- Pregnant females.
- Women of childbearing age/menstruating must have a negative pregnancy test before radiation therapy.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 to 4 weeks
Participants receive proton radiation therapy delivered daily from Monday to Friday for 3 to 4 weeks, depending on the prescribed dose. Each treatment session lasts 30 to 45 minutes with participants lying on a table.
Daily visits Monday to Friday for 3 to 4 weeks
Duration - Up to 5 years
Participants return to the clinic 3 to 6 months after their last radiation dose and then annually for up to 5 years for medical history, physical exams, diagnostic imaging, side effect assessments, and lung or heart function tests if needed.
Visits at 3 to 6 months post-treatment and then annually for up to 5 years
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Shannon M MacDonald, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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