protocolSection identificationModule nctId: NCT06344130, orgStudyIdInfo id: 10001859, secondaryIdInfos id: 001859-C, briefTitle: Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute (NCI), class: NIH, descriptionModule briefSummary: Background:Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy.Objective:To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment.Eligibility:People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment.Design:Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected.Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments.Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit.Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends.Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years., conditionsModule conditions: Astrocytoma, conditions: Glioma, conditions: Recurrent Glioblastoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ESTIMATED, armsInterventionsModule interventions name: Radiation Therapy, outcomesModule primaryOutcomes measure: MTD of daily re-irradiation in participants with recurrent grade 4 gliomas, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Compliance and feasibility of administering PRO in this participant population, secondaryOutcomes measure: Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother, secondaryOutcomes measure: Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities, secondaryOutcomes measure: Meaningful change in disease and treatment-related symptoms by using anchors, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 120 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Institutes of Health Clinical Center, city: Bethesda, state: Maryland, zip: 20892, country: United States, contacts name: National Cancer Institute Referral Office, role: CONTACT, phone: 888-624-1937, geoPoint lat: 38.98067, lon: -77.10026, hasResults: False