A Phase 1 interventional study of Radiation Therapy in Astrocytoma, Glioma and Recurrent Glioblastoma, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
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.
Background:
Objective:
-To determine the maximum tolerated dosage of daily re-irradiation in participants with recurrent Grade 4 gliomas
Eligibility:
Design:
until 5 years after treatment completion.
420 studies on the registry are indexed under Astrocytoma; 76 are open to participants now.
This study's planned enrollment of 28 is close to the median of 30 across 346 interventional studies indexed under Astrocytoma.
Browse Astrocytoma studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants must have adequate organ and marrow function as defined below:
EXCLUSION CRITERIA:
Recent systemic therapy prior to the initiation of the study therapy as follows:
Fraction size escalation of 3 planned re-irradiation dose levels.
Radiation: Radiation Therapy
MTD of re-irradiation dose.
Radiation: Radiation Therapy
Radiation therapy will be administered via a linear accelerator using 6 megavoltage (MV) photons or greater.
MTD of daily re-irradiation in participants with recurrent grade 4 gliomas
The number of participants experiencing DLTs within the DLT period will be reported for each hypofractionation schema. The MTD will be identified, and the proportion of participants treated with the MTD experiencing DLT will be reported.
Time frame: DLT period (28 days)
Progression free survival
Time to progression is defined as the interval from the initiation of treatment on protocol to progression or death. Estimates of the median time to progression and of the proportion of participants experiencing progression by 3 years or dying by 5 years will be obtained.
Time frame: Baseline, 30 day safety follow up visit, every 2 months for 2 years, every 3 months for 3rd year, or until progression
Overall survival
Overall survival is defined as the interval from initiation of treatment on protocol to the death. Estimates of the median time to overall survival will be obtained.
Time frame: Treatment and follow up
Compliance and feasibility of administering PRO in this participant population
Patient reported outcome forms will be checked versus the timing schedule and considered valid if they fall within the scheduled assessment window. Compliance rates, namely the number of received valid forms over the number of expected forms will be reported.
Time frame: Baseline through 3 years post radiation therapy.
Tolerability of treatment by assessing adverse events, cognitive function, physical function, and side effect bother
Tolerability of treatment will be assessed by determining the frequency of adverse events among treated participants and reporting the results by maximum grade of event and type of toxicity noted.
Time frame: First radiation treatment administration through 6 months after the last day of radiation. Beyond 6 months after radiation, only adverse events which are serious and related to radiation need to be recorded.
Longitudinally describe and evaluate disease and treatment-related symptom severity and interference with daily activities
Longitudinal changes in perceived cognition, disease and treatment-related symptom severity, and interference with daily activities will be evaluated and described. The proportion of participants rating their symptoms as mild , moderate, or severe for individual symptoms will be reported.
Time frame: Baseline through 3 years post radiation therapy.
Meaningful change in disease and treatment-related symptoms by using anchors
Meaningful change will be determined through both clinician-rated (Karnofsky) and participant-rated (PGI-Severity, PGI-Change) anchors from the MD Anderson Symptom Inventory for Brain Tumors and Montreal Cognitive Assessment.
Time frame: Baseline through 3 years post radiation therapy.
Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request. This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
Supporting information: Study protocol, Sap, Icf
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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National Cancer Institute (NCI)