OncoMatch/Clinical Trials/NCT06344130
Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
Is NCT06344130 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for astrocytoma.
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Prior therapy
Must have received: radiation therapy — curative-intent
Previous tumor irradiation to curative-intent doses.
Cannot have received: bevacizumab (bevacizumab)
Exception: used for tumor progression or symptomatic management
Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks.
Cannot have received: alkylating agent (temozolomide)
Temozolomide within 2 weeks.
Cannot have received: cytotoxic chemotherapy
Cytotoxic chemotherapy within 3 weeks.
Cannot have received: investigational agent
Any investigational agents within 2 weeks.
Cannot have received: any therapy after surgical re-resection or biopsy
Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy.
Cannot have received: radiation therapy
Requiring radiation therapy within 12 months prior to the initiation of study therapy.
Cannot have received: tumor treating fields (Novacure TTF)
History of prior therapy with Novacure TTF
Cannot have received: Gliadel wafers (Gliadel wafers)
History of prior therapy with...Gliadel wafers
Cannot have received: GammaTile therapy (GammaTile therapy)
History of prior therapy with...GammaTile therapy
Lab requirements
Blood counts
absolute neutrophil count (anc) >= 1,000/microl; platelets >= 100,000/microl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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