Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06055517
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-09-13
Brief Title:
Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma PULSAR
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
Centro di Riferimento Oncologico - Aviano
Study Overview
Official Title:
A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma PULSAR
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PULSAR
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None