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
717 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
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.
CONDITIONS
Official Title
Phase II Study of Proton Radiation Therapy for Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed neuroblastoma or ganglioneuroblastoma by tissue pathology or elevated urinary catecholamine metabolites.
- Participants aged between 3 and 25 years at diagnosis.
- Life expectancy must be greater than 12 months.
- ECOG performance status of 0, 1, or 2 (Karnofsky score ≥60%, Lansky score ≥60%).
- Diagnostic imaging (MRI and/or CT) of the treatment area within 8 weeks of treatment.
- Baseline bone marrow biopsy and bone scan or MIBG scan from original diagnosis.
- Women of child-bearing potential and men must agree to use effective contraception during the study.
- Ability and willingness of the patient or legal guardian to provide written informed consent before radiation therapy.
You will not qualify if you...
- Prior therapeutic radiation therapy exceeding 500 cGy.
- Chemotherapy completed 1 year or more before planned radiation start or radiation planned after relapse following chemotherapy alone.
- History of other malignancies unless disease-free for 5 years or low risk for recurrence, except recent cervical cancer in situ or skin basal/squamous cell carcinoma.
- Pregnant females.
- Women of childbearing age must have a negative pregnancy test before starting radiation therapy.
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
S
Shannon M MacDonald, MD
CONTACT
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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