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Proton Radiation for Benign or Indolent Brain Tumors

This study is looking at how well Proton Radiation works for adults with benign (non-cancerous) or indolent (slow-growing) brain tumors. Researchers want to see if Proton Radiation can control the tumor's growth and how it affects your quality of life and any side effects you might experience. You could be eligible if you are an adult with a biopsy-proven brain tumor that needs radiation, such as certain types of glioma, pituitary adenoma, vestibular schwannoma, or meningioma. The main goal is to measure how long the tumor stays under control for up to two years after treatment. The study aims to enroll 100 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures tumor control at 2 years, and investigators are also looking at effects up to 5 years after treatment.

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NCT03286335

Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy

Recruiting
NAAges 18+InterventionalTreatment
Massachusetts General Hospital
~100 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Proton Radiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Duration of Local Control
Measured over 2 years

Conditions

Brain Tumor

Explore related trials

Brain Neoplasm

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Helen A Shih, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Tarin Grillo
[email protected]
617-724-3661
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Biopsy-proven benign or malignant brain tumor requiring tumor bed or tumor irradiation. This may include, but is not limited to, low-grade or favorable high-grade glioma, pituitary adenoma, vestibular schwannoma (acoustic neuroma), and meningioma as the most common diagnoses. Other tumor types that require irradiation and are deemed appropriate for proton radiation therapy are also eligible. Patients with a presumed diagnosis based on imaging and clinical characteristics will be permitted on this trial without pathological diagnostic confirmation if it is within standard of care to offer radiation therapy without a biopsy.
Participants must otherwise be indicated for proton radiation therapy
Age 18 years or older
Karnofsky performance status ≥ 60 (see Appendix A)
Participants may have had any extent of prior surgery and/or chemotherapy.
Must be able to speak and comprehend English
Ability to understand and willingness to sign a written informed consent document
The effects of proton radiation therapy on the developing human fetus are known to be teratogenic. For this reason, 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, for the duration of study treatment, and 4 months after completion of proton therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study treatment, and 4 months after completion of proton therapy.
Life expectancy greater than or equal to 6 months.

Exclusion

Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or lactating women are excluded from this study because radiation is known to have teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiation therapy, breastfeeding should be discontinued if the mother is treated with radiation therapy.
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 3 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 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

What this trial measures

  • Duration of Local Control2 years

    The duration of local control will be measured from the start date of protocol radiation until the date of progressive disease. Local control is defined as the lack of tumor growth as determined by a brain MRI (magnetic resonance imaging). This will include tumors that appear unchanged in size as compared to the baseline pre-radiation scan and also tumors that appear slightly reduced in size as may occur in response to radiation therapy. Inflammation secondary to radiation therapy can radiographically mimic subtle disease progression and may need to be confirmed with serial imaging. Progression is defined as an increase in the size of the tumor, a significant increase in T2/FLAIR non-enhancing lesion on sable or increasing doses of corticosteroids compared to baseline, the appearance of any new lesion, clear clinical deterioration not attributable to any other cause apart from the tumor, or failure to return for evaluation due to death or deteriorating condition.