Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
ConditionGlioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentro di Riferimento Oncologico - Aviano
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥18 years;
Ability to express appropriate informed consent to treatment;
Diagnosis of cerebral glioma;
Histological/radiological confirmation of disease recurrence/relapse;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Pulsed low dose-rate radiotherapy (pLDRT)
RadiationRadiation treatment will be carried out with high-energy photons (6MV) using intensity modulated radiation therapy (IMRT) or volumetric arc radiation therapy (VMAT). The daily dose is 2 Gy, divided into 10 subfractions of 0.2 Gy spaced by 3 minutes. The cumulative dose will be individualized for each patient and can range from a minimum of 40 Gy to a maximum of 60 Gy.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: Pulsed low dose-rate radiotherapy (pLDRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
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
Time frame
up to 5 yearsSecondary outcomes
1
To assess the median time to local disease progression
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.
Time frame
up to 5 years2
To assess the median survival time
Assessment of median survival time. Survival will be defined as the time from study enrollment until death for any cause
Time frame
up to 5 years3
To assess the incidence of toxicities other than radionecrosis
Assessment of incidence of other neurological toxicities graded with the scale CTCAE v 5.0
Time frame
up to 5 years4
To assess the presence of biomarkers associated with the actinic toxicity
Frequency of selected circulating biomarkers in patients with actinic toxicity
Time frame
up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov