Phase II Study of Proton Radiation Therapy for Neuroblastoma

This study is looking at a type of radiation therapy called proton beam radiation therapy (PBRT) for people with neuroblastoma or ganglioneuroblastoma. Neuroblastoma is a cancer that often starts in the adrenal glands or other areas with nerve cells. Standard treatment often uses conventional radiation (photons). This study wants to see if proton radiation, which is known to spare healthy tissues, can be a good alternative. The study will look at how well proton radiation works and any side effects, both short-term and long-term (up to 5 years). About 30 participants between 6 months and 25 years old can join if they have a confirmed diagnosis.

Study design: This is a Phase II interventional study, meaning it tests a specific treatment. It plans to include 30 participants.
What's involved: You would receive proton radiation daily for 3-4 weeks (Monday-Friday) at Massachusetts General Hospital, with each session lasting 30-45 minutes. You would also have weekly physical exams, side effect assessments, and blood tests during treatment, followed by annual visits for up to 5 years.
Compensation: Not stated in the trial record.
Follow-up: Participants will have follow-up visits for up to 5 years after their last radiation treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Phase II Study of Proton Radiation Therapy for Neuroblastoma

Active, Not Recruiting

NAAges 6–25InterventionalTreatment

Massachusetts General Hospital

~30 participants

Updated 2026-08-20 on ClinicalTrials.gov

What's tested:Proton Beam Radiation Therapy

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma

Measured over 5 years

+1 more outcome measured

Conditions

Neuroblastoma

Ganglioneuroblastoma

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

Shannon M. MacDonald, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have histologically confirmed neuroblastoma or ganglioneuroblastoma or elevated urinary catecholamine metabolites. If tumor tissue was obtained, pathological review of surgical specimen at the Massachusetts General Hospital or other DF/HCC institution is required, but preliminary report only required prior to enrollment. If no tumor tissue was obtained, urinary catecholamine metabolites are required.

Participants do not need to have measurable disease at the time of radiation. Age ≥ 3 and ≤ 25 years at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population.

Life expectancy of greater than 12 months.

ECOG performance status ≤2 (Karnofsky ≥60%, Lansky ≥60%, see Appendix A).

Diagnostic Imaging MRI and/or CT of the area to be treated within 8 weeks of any treatment. Baseline bone marrow biopsy and bone scan (with 99mTc-diphosphonate or MIBG scan (131I-MIBG or 123I-MIBG) from time of original diagnosis is required.

Because radiation is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Ability of the patient or the patient's legal guardian to understand and the willingness to sign a written informed consent document.

Participants or their legal guardian must sign consent prior to the initiation of radiation therapy.

Exclusion

Patients will be ineligible if any prior therapeutic radiation therapy \> 500 cGy has been delivered.

Patients will be ineligible if chemotherapy was completed ≥ 1 year from the planned start date of radiation therapy or if the patient is referred for radiation therapy after a relapse following a regimen with chemotherapy alone.

Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

What this trial measures

Describe late complications of radiation therapy delivered with proton radiotherapy in place of photon radiation for patients with neuroblastoma5 years
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.
To evaluate acute and subacute toxicities of proton radiotherapy in place of photon radiation for patients with neuroblastoma.5 years
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.

Trialytics