Recruiting

Proton Radiation Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT03286335

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Proton Radiation

Study Details

Brief summary:

This research study is studying Proton Radiation as a possible treatment for brain tumor.

The radiation involved in this study is:

-Proton Radiation

Conditions

Brain Tumor

Study ID

NCT03286335

Start date

Sep 26, 2018

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Proton Radiation

  • Radiation therapy will be delivered typically five (5) days per week on weekdays
  • Proton Radiation dose be determine by histology

Interventions

Proton Radiation

Radiation treatment

Primary outcome measure

  • Duration of Local Control [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Tarin Grillo

617-724-3661TGRILLO@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02214

Contacts

Tarin Grillo

617-724-3661TGRILLO@mgh.harvard.edu

Principal Investigator:

Helen A Shih, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Brain Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-08-24.