NCT06055517

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

A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Centro di Riferimento Oncologico - Aviano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioma

Interventions

Type	Name	Description
RADIATION	Pulsed low dose-rate radiotherapy (pLDRT)	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.

Timeline

• Start date: 2023-05-26
• Primary completion: 2028-05-26
• Completion: 2028-05-26
• First posted: 2023-09-26
• Last updated: 2023-09-26

Locations

1 site across 1 country: Italy