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

Glioma Clinical Trial

— PULSAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055517
• Other study ID #: CRO-2022-82
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: May 26, 2028

Study information

• Verified date: September 2023
• Source: Centro di Riferimento Oncologico - Aviano
• Contact: Lorenzo Vinante, MD
• Phone: 0434659855
• Email: lorenzo.vinante[@]cro.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: May 26, 2028
• Est. primary completion date: May 26, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano	Aviano	Pordenone

Sponsors (1)

Lead Sponsor	Collaborator
Centro di Riferimento Oncologico - Aviano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To 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	up to 5 years
Secondary	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.	up to 5 years
Secondary	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	up to 5 years
Secondary	To assess the incidence of toxicities other than radionecrosis	Assessment of incidence of other neurological toxicities graded with the scale CTCAE v 5.0	up to 5 years
Secondary	To assess the presence of biomarkers associated with the actinic toxicity	Frequency of selected circulating biomarkers in patients with actinic toxicity	up to 5 years
Secondary	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	up to 5 years
Secondary	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	up to 5 years
Secondary	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	up to 5 years