Pulsed low-dose rate re-irradiation for recurrent glioma
Official title: A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
Run by Centro di Riferimento Oncologico - Aviano · NCT06055517 · Data updated 2026-11-12
This study is testing a new way of giving radiation therapy to people with recurrent gliomas to see if it can help treat their condition safely while reducing side effects.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 29 (estimated) |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Aviano, Pordenone) |
| Status | Recruiting |
| Started | May 26, 2023 |
| Main results expected | May 26, 2028 |
| Study ends | May 26, 2028 |
| Registry record updated | September 26, 2023 |
| Trial ID | NCT06055517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with a confirmed diagnosis of recurrent cerebral glioma who have completed prior radiation therapy at least six months before enrollment.
✕Probably not a fit
Patients who are currently pregnant, have leptomeningeal spread of disease, or are receiving concomitant chemotherapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the use of pulsed low-dose rate radiotherapy (pLDRT) as a treatment option for patients with recurrent gliomas. The approach aims to minimize the risk of symptomatic radionecrosis while allowing for higher cumulative radiation doses beyond the conventional limit of 100 Gy. By leveraging the cellular hyper-radiosensitivity at low dose rates, the study seeks to determine the safety and efficacy of this innovative re-irradiation technique. Participants will receive pLDRT after having previously undergone radiation therapy at least six months prior.
Why it matters
Potential benefit: If successful, this treatment could provide a safer re-irradiation option for patients with recurrent gliomas, potentially improving their outcomes.
How similar studies have gone: While the use of pulsed low-dose rate radiotherapy is a novel approach, similar studies in other contexts have shown promise in reducing radiotoxicity.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Ability to express appropriate informed consent to treatment; * Diagnosis of cerebral glioma; * Histological/radiological confirmation of disease recurrence/relapse; * Previous brain-level radiation therapy completed a minimum of 6 months; * Performance status: ECOG=0-2. Exclusion Criteria: * Refusal to radiation treatment (i.e., absence of informed consent signed); * Concomitant chemotherapy; * Leptomeningeal spread of disease and localization in both cerebral hemispheres; * Current pregnancy.
Where it's running
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IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordenone, Italy Recruiting
Study contacts
- Principal investigator: Lorenzo Vinante, MD — Centro di Riferimento Oncologico di Aviano (CRO)
- Study coordinator: Lorenzo Vinante, MD
- Email: lorenzo.vinante@cro.it
- Phone: 0434659855
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.