Second radiation blast targets recurrent brain tumors
NCT ID NCT06344130
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 4 times
Summary
This early-phase trial tests a new way to give radiation to people whose glioblastoma (a severe brain cancer) has come back after initial treatment. About 28 adults will receive focused radiation over 1 to 3 weeks, with different schedules to find the safest dose. The goal is to control the tumor and improve survival, but the study is small and exploratory.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy (re-irradiation)
- What this could lead to
- If successful, this could establish a safer, more effective radiation schedule to control recurrent glioblastoma and potentially extend survival.
- What could go wrong
- This is a very early phase 1 trial with only 28 participants, so results may not apply broadly. Re-irradiation carries risks of brain damage, and the tumor may still progress.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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. EXCLUSION CRITERIA: * 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. * Participants who are unable to undergo MRI evaluation or receive gadolinium contrast for any reason. * 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. * Positive beta-human chorionic gonadotropin (HCG) pregnancy test performed in individuals of childbearing potential at screening. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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