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.
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
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 one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
A female of childbearing potential (FCBP) is a sexually mature woman who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (if age >= 55 years); if the female subject is < 55 years and she has been naturally postmenopausal for >= 1 year her reproductive status has to be verified by additional laboratory (lab) tests (< 20 estradiol OR estradiol < 40 with follicle stimulating hormone [FSH] > 40 in women not on estrogen replacement therapy)
Prior radiation therapy that would overlap with current target volume
Inability to undergo magnetic resonance imaging (MRI)
Parallel
Hypofractionated Radiation Therapy
RadiationUndergo hypofractionated proton or photon radiation therapy
Photon Beam Radiation Therapy
RadiationUndergo hypofractionated proton or photon radiation therapy
Proton Beam Radiation Therapy
RadiationUndergo hypofractionated proton or photon radiation therapy
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
local tumor control
Will assess local tumor control rate. Local tumor control is defined as freedom from progressive disease (PD). Will be calculated as the proportion of patients who did not experience PD within 3-year follow up with 95% binomial proportion confidence interval for the entire population and each cohort independently. The same calculation will be repeated for the entire study population and each cohort separately. Kaplan-Meier method will be used to estimate the local control rates for the entire population and each cohort independently.
Incidence of adverse events
Will be assessed and graded according to Common Terminology Criteria for Adverse Events version 5.0
Neurocognitive effects
Will be summarized by summary statistics.
Health related quality of life
Will be summarized by summary statistics.
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
