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

Recruiting

HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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)

About the study

This phase II trial studies how well hypofractionated proton or photon radiation therapy works in treating patients with brain tumors. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells. A shorter duration of radiation treatment may avoid some of the delayed side effects of radiation while providing a more convenient treatment and reducing costs.

What is being tested

Sponsor: Emory University · Participants: 70 · Started: Feb 18, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04278118

Locations in the U.S.

GeorgiaEmory University Hospital/Winship Cancer Institute, Atlanta

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.