HiPPI: A Phase 2 Trial of Hypofractionated Pencil Beam Scanning Proton Therapy for Benign Intracranial Tumors
Status: Recruiting
Location: See location...
Intervention Type: Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Georgia
Emory University Hospital/Winship Cancer Institute
RECRUITING
Atlanta
Time Frame
Start Date: 2020-02-18
Estimated Completion Date: 2031-12-01
Participants
Target number of participants: 70
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Emory University
Collaborators: National Cancer Institute (NCI)