Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
Recruiting now · Not applicable
Conditions studied: Glioma
In brief
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.
Key facts
- Study ID
- NCT06055517
- Run by
- Centro di Riferimento Oncologico - Aviano
- People needed
- 29
- Starts
- 2023-05-26
- Expected to finish
- 2028-05-26
- Last updated by the study team
- 2023-09-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano — Aviano, Pordenone, Italy (enrolling)
Full record on ClinicalTrials.gov
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