NCT06055517 Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
| NCT ID | NCT06055517 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centro di Riferimento Oncologico - Aviano |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 29 participants |
| Start Date | 2023-05-26 |
| Primary Completion | 2028-05-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 29 participants in total. It began in 2023-05-26 with a primary completion date of 2028-05-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Re-irradiation in gliomas is a therapeutic option at recurrence before of 2nd-line chemotherapy. The dose of re-irradiation with conventional fractionation is unfortunately limited by the risk of symptomatic radionecrosis that is significant for cumulative doses above 100 Gy. The use of unconventional low dose rate pulsed radiotherapy (pLDRT) can reduce the risk of radiotoxicity while taking advantage of the cellular hyper-radiosensitivity that occurs at low dose-rates. The present study therefore aims at evaluating whether the use of pLDRT in the re-irradiation of recurrences of gliomas allows maintaining a low risk of symptomatic radionecrosis even for cumulative doses greater than 100 Gy.
Eligibility 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.
Contact & Investigator
Lorenzo Vinante, MD
PRINCIPAL INVESTIGATOR
Centro di Riferimento Oncologico di Aviano (CRO)
Frequently Asked Questions
Who can join the NCT06055517 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06055517 currently recruiting?
Yes, NCT06055517 is actively recruiting participants. Contact the research team at lorenzo.vinante@cro.it for enrollment information.
Where is the NCT06055517 trial being conducted?
This trial is being conducted at Aviano, Italy.
Who is sponsoring the NCT06055517 clinical trial?
NCT06055517 is sponsored by Centro di Riferimento Oncologico - Aviano. The principal investigator is Lorenzo Vinante, MD at Centro di Riferimento Oncologico di Aviano (CRO). The trial plans to enroll 29 participants.