Clinical trial NCT06055517: Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
Official title: A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glioma
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
timeFrame: up to 5 years
Secondary outcomes:
measure: To assess the median time to local disease progression
timeFrame: up to 5 years
measure: To assess the median survival time
timeFrame: up to 5 years
measure: To assess the incidence of toxicities other than radionecrosis
timeFrame: up to 5 years
measure: To assess the presence of biomarkers associated with the actinic toxicity
timeFrame: up to 5 years
measure: To assess the presence of biomarkers associated with response to therapy
timeFrame: up to 5 years
measure: To assess the presence of biomarkers associated with overall survival (OS)
timeFrame: up to 5 years
measure: To evaluate the immunomodulation induced by the pulsed schedule in comparison with the conventional schedule
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico di Aviano (CRO)
name: Lorenzo Vinante, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro di Riferimento Oncologico di Aviano (CRO)
name: Lorena Baboci, PhD
role: PRINCIPAL_INVESTIGATOR
References: