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Hypofractionated Proton Therapy for Benign Brain Tumors

This study is testing a type of radiation therapy called hypofractionated proton or photon radiation therapy for people with certain benign (non-cancerous) brain tumors, including meningiomas and nerve sheath tumors. Hypofractionated radiation therapy delivers higher doses of radiation over a shorter time, which might kill more tumor cells and reduce some delayed side effects. The study aims to see how well this treatment controls the tumor and to track any side effects over three years. You might be able to join if you are 18 or older, have a diagnosed benign brain or nerve sheath tumor, and are recommended for radiation therapy. The study plans to enroll 70 participants.

Study design
This is an interventional study with two cohorts, planning to enroll 70 participants. It is not specified if it is a randomized or blinded study.
What's involved
Participants will receive hypofractionated proton or photon radiation therapy daily, Monday-Friday, for 3.5-4 weeks. They will also complete quality-of-life assessments and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up periodically for up to 3 years after treatment to check for tumor control and adverse events.

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NCT04278118

Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study

Recruiting
NAAges 18+InterventionalTreatment
Emory University
~70 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:Hypofractionated Radiation TherapyPhoton Beam Radiation TherapyProton Beam Radiation TherapyQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
local tumor control
Measured over Up to 3 years since enrollment
+1 more outcome measured

Conditions

Grade I Meningioma
Grade II Meningioma
Grade III Meningioma
Intracranial Neoplasm
Nerve Sheath Neoplasm
Pituitary Gland Adenoma
Schwannoma

Explore related trials

Intracranial NeoplasmMeningiomaNerve Sheath NeoplasmPituitary Neuroendocrine TumorSchwannoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Bree R Eaton · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Bree R. Eaton
[email protected]
404-251-2690
Email the study team

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Eligibility criteria

Inclusion

Pathologically or radiographically diagnosed benign intracranial or nerve sheath tumor, including meningiomas, pituitary adenomas, schwannomas. World Health Organization (WHO) grade 2-3 meningiomas are also allowed
Recommended to receive proton or photon fractionated radiation therapy
Signed informed consent

Exclusion

Pregnant females are excluded. Female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy. FCBP must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
A female of childbearing potential (FCBP) is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (if age \>= 55 years); if the female subject is \< 55 years and she has been naturally postmenopausal for \>= 1 year her reproductive status has to be verified by additional laboratory (lab) tests (\< 20 estradiol OR estradiol \< 40 with follicle stimulating hormone \[FSH\] \> 40 in women not on estrogen replacement therapy)
Prior radiation therapy that would overlap with current target volume
Inability to undergo magnetic resonance imaging (MRI)

What this trial measures

  • local tumor controlUp to 3 years since enrollment

    Will assess local tumor control rate. Local tumor control is defined as freedom from progressive disease (PD). Will be calculated as the proportion of patients who did not experience PD within 3-year follow up with 95% binomial proportion confidence interval for the entire population and each cohort independently. The same calculation will be repeated for the entire study population and each cohort separately. Kaplan-Meier method will be used to estimate the local control rates for the entire population and each cohort independently.

  • Incidence of adverse eventsup to 3 years

    Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0