Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
- Conditions
- Glioma
- Interventions
- Radiation: Pulsed low dose-rate radiotherapy (pLDRT)
- Registration Number
- NCT06055517
- Lead Sponsor
- Centro di Riferimento Oncologico - Aviano
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 29
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pulsed low dose-rate radiotherapy (pLDRT) Pulsed low dose-rate radiotherapy (pLDRT) -
- Primary Outcome Measures
Name Time Method To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule up to 5 years Incidence of grade \>=2 brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule, defined according to CTCAE v5.0 scale
- Secondary Outcome Measures
Name Time Method To assess the presence of biomarkers associated with the actinic toxicity up to 5 years Frequency of selected circulating biomarkers in patients with actinic toxicity
To assess the presence of biomarkers associated with response to therapy up to 5 years Difference in progression free survival (PFS) probability between groups of patients with or without selected circulating biomarkers. PFS will be defined as the time from study enrollment until progression or death for any cause, whichever comes first. Median survival for each biomarker will be calculated
To assess the presence of biomarkers associated with overall survival (OS) up to 5 years Difference in OS probability between groups of patients with or without selected circulating biomarkers. OS will be defined as the time from study enrollment until death for any cause
To assess the median survival time up to 5 years Assessment of median survival time. Survival will be defined as the time from study enrollment until death for any cause
To assess the median time to local disease progression up to 5 years Assessment of median disease progression-free survival. PFS will be defined as the time from study enrollment until progression or death for any cause, whichever comes first. Disease progression defined according to RANO criteria.
To assess the incidence of toxicities other than radionecrosis up to 5 years Assessment of incidence of other neurological toxicities graded with the scale CTCAE v 5.0
To evaluate the immunomodulation induced by the pulsed schedule in comparison with the conventional schedule up to 5 years Difference in the frequency of immunotherapeuthic markers between pulsed and conventional radiotherapy schedules
Trial Locations
- Locations (1)
IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
🇮🇹Aviano, Pordenone, Italy