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

What this Trial Is About

Researchers are evaluating how well hypofractionated proton or photon radiation therapy works in treating patients with benign intracranial brain tumors, including certain meningiomas and nerve sheath tumors. This phase II trial aims to see if delivering higher doses of radiation over a shorter period can control tumors effectively while reducing delayed side effects, treatment time, and costs. The study also examines the feasibility of this approach and its effects on neurocognitive function, quality of life, and reported toxicities. Participants are assigned to one of two groups based on tumor type. Cohort I includes patients with benign radiographically diagnosed intracranial tumors who receive radiation therapy daily Monday through Friday over 17 fractions spanning 3.5 to 4 weeks. Cohort II consists of patients with pathologically confirmed WHO grade 2-3 meningiomas treated daily Monday through Friday over 20 fractions in the same time frame. Radiation may be delivered using proton or photon beams depending on the group, and treatment continues without disease progression or unacceptable toxicity. During the study, participants undergo regular follow-up visits to monitor tumor control and any adverse events for up to three years after enrollment. Researchers assess neurocognitive effects, health-related quality of life, and patient-reported toxicity throughout this period. Evaluations include imaging and questionnaires, with safety monitored closely. The total monitoring period ensures thorough observation of treatment outcomes and side effects over time.

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