Tests radiation schedules for glioblastoma that returned after earlier radiation
Tests shorter radiation schedules in adults whose glioblastoma brain tumor returned.
Plain-language title generated from the registry record
Registry title: Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
Key facts
- Where
- Bethesda, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 120 years old?
Source: NCT06344130, who can take part
Where in United States
- National Institutes of Health Clinical CenterBethesda, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Cancer Institute (NCI)
- Trial code
- NCT06344130
- Record updated
- 16 October 2026
- Original description
Background:Read full original descriptionShow less
A Phase I Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
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.
Exclusion: Recent systemic therapy prior to the initiation of the study therapy as follows:; Bevacizumab used for reasons other than tumor progression or symptomatic management within 2 weeks; Temozolomide within 2 weeks; Cytotoxic chemotherapy within 3 weeks; Any investigational agents within 2 weeks; Any prior therapy after surgical re-resection or biopsy within 2 weeks prior to the initiation of the study therapy; Requiring radiation therapy within 12 months prior to the initiation of study therapy; History of prior therapy with Novacure TTF, Gliadel wafers, or GammaTile therapy; Participants with known or suspected radiation sensitivity syndromes; Uncontrolled intercurrent illness evaluated by medical history and physical exam that are not stable and would potentially increase the risk to the participant; Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason; Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening.
INCLUSION CRITERIA:; Histologic diagnosis of primary glioblastoma or gliosarcoma of the brain, or secondary glioblastoma of the brain due to transformation from a lower grade to a grade 4 tumor; Age >= 18; KPS >= 70%; Previous tumor irradiation to curative-intent doses; Radiation dose constraints must be achievable based on assessment with MRI and treatment planning CT; Participants must have adequate organ and marrow function as defined below:; Absolute neutrophil count (ANC) >= 1,000/microL; Platelets >= 100,000/microL; Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use effective contraception (barrier, hormonal, intrauterine device, surgical sterilization, abstinence) from study entry and through 6 months after the last study treatment (restricted period). Individuals who can father children must not freeze or donate sperm within the same period; Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last study treatment; The ability of a participant to understand and the willingness to sign a written informed consent document.