Who is eligible for clinical trial NCT03286335?

Participants must meet protocol criteria for Brain Tumor. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT03286335 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-20

Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy (NCT03286335)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Massachusetts General Hospital

🩺 Plain-English Summary (8th-Grade Level)

This research study is studying Proton Radiation as a possible treatment for brain tumor. The radiation involved in this study is: -Proton Radiation

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (4 items).

Location: Massachusetts General Hospital — Boston, Massachusetts

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Massachusetts General Hospital — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗