Hypofractionated Proton or Photon Radiation Therapy for the Treatment of Brain Tumors, the HiPPI Study

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor	NCT ID:	NCT04278118
Trial Phases:	Phase II	Protocol IDs:	RAD4811-19 (primary) NCI-2019-06446 IRB00114529
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04278118

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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