Hypofractionated Proton Therapy for Benign Intracranial Brain Tumors, the HiPPI Study (HiPPI)
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ClinicalTrials.gov Identifier: NCT04278118 |
Recruitment Status :
Recruiting
First Posted : February 20, 2020
Last Update Posted : May 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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Grade I Meningioma Grade II Meningioma Grade III Meningioma Intracranial Neoplasm Nerve Sheath Neoplasm Pituitary Gland Adenoma Schwannoma | Radiation: Hypofractionated Radiation Therapy Radiation: Photon Beam Radiation Therapy Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment Other: Questionnaire Administration | Not Applicable |
PRIMARY OBJECTIVE:
I. To report 3 year local tumor control of moderately hypofractionated proton or photon therapy for benign intracranial tumors.
SECONDARY OBJECTIVES:
I. 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors |
Actual Study Start Date : | February 18, 2020 |
Estimated Primary Completion Date : | April 30, 2023 |
Estimated Study Completion Date : | April 30, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort I (hypofractionated radiation therapy)
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.
|
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
Other Names:
Radiation: Photon Beam Radiation Therapy Undergo hypofractionated proton or photon radiation therapy Radiation: Proton Beam Radiation Therapy Undergo hypofractionated proton or photon radiation therapy
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
Experimental: Cohort II (hypofractionated radiation therapy)
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.
|
Radiation: Hypofractionated Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
Other Names:
Radiation: Photon Beam Radiation Therapy Undergo hypofractionated proton or photon radiation therapy Radiation: Proton Beam Radiation Therapy Undergo hypofractionated proton or photon radiation therapy
Other Names:
Other: Quality-of-Life Assessment Ancillary studies
Other Name: Quality of Life Assessment Other: Questionnaire Administration Ancillary studies |
- local tumor control [ Time Frame: Up 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 events [ Time Frame: up to 3 years ]Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0
- Neurocognitive effects [ Time Frame: Up to 3 years ]Will be summarized by summary statistics.
- Health related quality of life [ Time Frame: Up to 3 years ]Will be summarized by summary statistics.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278118
United States, Georgia | |
Emory University Hospital/Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Bree R. Eaton 404-251-2690 brupper@emory.edu | |
Principal Investigator: Bree R. Eaton |
Principal Investigator: | Bree R Eaton | Emory University Hospital/Winship Cancer Institute |
Responsible Party: | Bree Eaton, Principal Investigator, Emory University |
ClinicalTrials.gov Identifier: | NCT04278118 |
Other Study ID Numbers: |
IRB00114529 NCI-2019-06446 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) RAD4811-19 ( Other Identifier: Emory University Hospital/Winship Cancer Institute ) P30CA138292 ( U.S. NIH Grant/Contract ) |
First Posted: | February 20, 2020 Key Record Dates |
Last Update Posted: | May 25, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Neoplasms Adenoma Meningioma Neurilemmoma Brain Neoplasms Nerve Sheath Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms, Nerve Tissue |
Neoplasms, Vascular Tissue Meningeal Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroma Peripheral Nervous System Neoplasms Peripheral Nervous System Diseases Neuromuscular Diseases |