HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
Emory University
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.
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 pa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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: * 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 o…
Interventions
- RadiationHypofractionated Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
- RadiationPhoton Beam Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
- RadiationProton Beam Radiation Therapy
Undergo hypofractionated proton or photon radiation therapy
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia