NCT04278118

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated proton or photon radiation therapy
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	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-02-18
• Primary completion: 2030-12-01
• Completion: 2031-12-01
• First posted: 2020-02-20
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States