This clinical trial studies the local control, quality of life, late toxicities in patients with brain tumors following proton beam radiation therapy. Proton beam radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Evaluating local control and quality of life may help to define pre-irradiation versus post-irradiation functional changes in patients following proton beam radiation therapy.
Additional locations may be listed on ClinicalTrials.gov for NCT03286335.
Locations matching your search criteria
United States
Massachusetts
Boston
Massachusetts General Hospital Cancer CenterStatus: Active
Contact: Helen A Shih
Phone: 617-724-9627
PRIMARY OBJECTIVE:
I. To document local control at 2 and 5 years after proton beam radiation therapy (proton radiation therapy) in adults with low-grade and indolent brain tumors per tumor type.
SECONDARY OBJECTIVES:
I. To characterize the quality of life changes that occur in adults following treatment with proton radiation therapy for brain tumors.
II. To describe the incidence, severity, and timing of onset of vision loss in adults who receive proton therapy to or in proximity to any of the eyes, optic nerves, or optic chiasm.
III. To describe the incidence, severity, and timing of onset of ototoxicity in adults who receive proton therapy to or in proximity to the cochlea.
IV. To describe the incidence, severity, and timing of onset of neuroendocrine dysfunction in adults who receive proton therapy to or in proximity to the pituitary.
V. To describe the incidence, severity, and timing of onset of neurocognitive effects in adults who receive proton therapy to any part of the brain.
VI. To detail the extent of alopecia that may occur and correlate with the radiation treatment delivered.
VII. To assess the change in white blood cell counts (including leukocytes, lymphocytes, CD4 counts, macrophages, and monocytes), and inflammatory markers (circulating cytokines) as a result of receiving radiation therapy and to correlate such changes with tumor type, radiation treatment volume, neurocognitive function, structural brain changes and patient outcome measures.
OUTLINE:
Patients undergo proton beam radiation therapy daily 5 days per week on weekdays for up to 7.5 weeks. Patients also undergo blood sample collection throughout the trial and undergo magnetic resonance imaging (MRI) at screening and during follow-up.
After completion of study treatment, patients are followed up at 3 months, 6 months, and 1, 2, 3, and 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorHelen A Shih
