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

NCT04278118 | Recruiting DMC

• 4 other identifiers: IRB00114529NCI-2019-06446RAD4811-19P30CA138292
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  up to 3 years

Secondary Outcomes (2)

• Neurocognitive effects

  Up to 3 years

• Health related quality of life

  Up to 3 years

Study Arms (2)

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.

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.

Radiation: Hypofractionated Radiation Therapy; Radiation: Photon Beam Radiation Therapy; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Hypofractionated Radiation Therapy RADIATION

Undergo hypofractionated proton or photon radiation therapy

Also known as: Hypofractionated Radiotherapy, hypofractionation

Cohort I (hypofractionated radiation therapy); Cohort II (hypofractionated radiation therapy)

Photon Beam Radiation Therapy RADIATION

Undergo hypofractionated proton or photon radiation therapy

Cohort I (hypofractionated radiation therapy); Cohort II (hypofractionated radiation therapy)

Proton Beam Radiation Therapy RADIATION

Undergo hypofractionated proton or photon radiation therapy

Also known as: PBRT, Proton Radiation Therapy, Radiation, Proton Beam

Cohort I (hypofractionated radiation therapy); Cohort II (hypofractionated radiation therapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Cohort I (hypofractionated radiation therapy); Cohort II (hypofractionated radiation therapy)

Questionnaire Administration OTHER

Ancillary studies

Cohort I (hypofractionated radiation therapy); Cohort II (hypofractionated radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Meningioma; Brain Neoplasms; Nerve Sheath Neoplasms; Pituitary Neoplasms; Neurilemmoma

Interventions

Radiation Dose Hypofractionation; Proton Therapy; Protons

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Peripheral Nervous System Neoplasms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroma

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics; Heavy Ion Radiotherapy; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Bree R Eaton

  Emory University Hospital/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 20, 2020
• Study Start: February 18, 2020
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-01

Locations

US (1)