Pulsed low-dose rate re-irradiation for recurrent glioma
A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centro di Riferimento Oncologico - Aviano Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Aviano, Pordenone) |
| Trial ID | NCT06055517 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are currently pregnant, have leptomeningeal spread of disease, or are receiving concomitant chemotherapy may not benefit from this study.
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 performed: While the use of pulsed low-dose rate radiotherapy is a novel approach, similar studies in other contexts have shown promise in reducing radiotoxicity.
Eligibility criteria
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 this trial is running
Aviano, Pordenone
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.