Grade I MeningiomaHiPPINCT04278118
Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study
A study testing Hypofractionated Radiation Therapy, Photon Beam Radiation Therapy and Proton Beam Radiation Therapy in people with Grade I Meningioma and Grade II Meningioma, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade I Meningioma, Grade II Meningioma, Grade III Meningioma
- What is being tested?
- Hypofractionated Radiation Therapy, Photon Beam Radiation Therapy and Proton Beam Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 1 Dec 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Bree R. Eaton, 404-251-2690, brupper@emory.edu
Bree R. Eaton
About this study
Official title: HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To report 3 year local tumor control of moderately hypofractionated proton or photon therapy for benign intracranial tumors.
SECONDARY OBJECTIVES:
- To demonstrate feasibility of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors.
II. To report physician reported acute and late toxicity of moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
III. To report neurocognitive effects, health related quality of life, and patient reported toxicity for moderate hypofractionation pencil beam scanning proton therapy for intracranial tumors.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients with benign and radiographically diagnosed intracranial tumors undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 17 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.
COHORT II: Patients with pathologically confirmed World Health Organization (WHO) grade 2-3 meningiomas undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 20 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
- Conditions
- Grade I Meningioma, Grade II Meningioma, Grade III Meningioma, Intracranial Neoplasm, Nerve Sheath Neoplasm, Pituitary Gland Adenoma
- Being tested
- Hypofractionated Radiation Therapy, Photon Beam Radiation Therapy, Proton Beam Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Meningioma, Brain Neoplasms, Nerve Sheath Neoplasms, Pituitary Neoplasms, Neurilemmoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated Radiotherapy, hypofractionation
Undergo hypofractionated proton or photon radiation therapy
Photon Beam Radiation TherapyRadiation
Undergo hypofractionated proton or photon radiation therapy
Proton Beam Radiation TherapyRadiation
Also called PBRT, Proton Radiation Therapy, Radiation, Proton Beam
Undergo hypofractionated proton or photon radiation therapy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (hypofractionated radiation therapy) | Experimental | Patients with benign and radiographically diagnosed intracranial tumors undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 17 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Radiation: Hypofractionated Radiation Therapy; Radiation: Photon Beam Radiation Therapy; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Cohort II (hypofractionated radiation therapy) | Experimental | Patients with pathologically confirmed World Health Organization (WHO) grade 2-3 meningiomas undergo hypofractionated proton or photon radiation therapy daily, Monday-Friday over 20 fractions for 3.5-4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Radiation: Hypofractionated Radiation Therapy; Radiation: Photon Beam Radiation Therapy; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
local tumor control
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.
Measured: Up to 3 years since enrollment
Incidence of adverse events
Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0
Measured: up to 3 years
Secondary outcomes (2)
Neurocognitive effects
Will be summarized by summary statistics.
Measured: Up to 3 years
Health related quality of life
Will be summarized by summary statistics.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start18 Feb 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade I MeningiomaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bree Eaton, Emory University
- Investigators
- Bree R Eaton, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278118
- Sponsor's protocol ID
- IRB00114529
- Other IDs
- NCI-2019-06446, RAD4811-19, P30CA138292
- Acronym
- HiPPI
- Status last verified
- Jan 2026
- First submitted
- 7 Feb 2020
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided