Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)

Centro di Riferimento Oncologico - Aviano

Status: Enrolling

Conditions: Glioma

Treatments: Radiation: Pulsed low dose-rate radiotherapy (pLDRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06055517

CRO-2022-82

Details and patient eligibility

About

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.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Pulsed low dose-rate radiotherapy (pLDRT)

Experimental group

Treatment:

Radiation: Pulsed low dose-rate radiotherapy (pLDRT)