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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Radiation 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.
IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordenone, Italy
RECRUITINGTo 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 years
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 years
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 years
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 years
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 years
To assess the presence of biomarkers associated with response to therapy
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
Time frame: up to 5 years
To assess the presence of biomarkers associated with overall survival (OS)
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
Time frame: up to 5 years
To evaluate the immunomodulation induced by the pulsed schedule in comparison with the conventional schedule
Difference in the frequency of immunotherapeuthic markers between pulsed and conventional radiotherapy schedules
Time frame: up to 5 years
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