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

NCT ID: NCT06055517

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2028-05-26

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.

Conditions

Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulsed low dose-rate radiotherapy (pLDRT)

Group Type: EXPERIMENTAL

Pulsed low dose-rate radiotherapy (pLDRT)

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro di Riferimento Oncologico - Aviano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorenzo Vinante, MD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Lorena Baboci, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro di Riferimento Oncologico di Aviano (CRO)

Locations

IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordenone, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lorenzo Vinante, MD

Role: CONTACT

lorenzo.vinante@cro.it

0434659855

Facility Contacts

Lorenzo Vinante, MD

Role: primary

lorenzo.vinante@cro.it

+390434659855

Other Identifiers

CRO-2022-82

Identifier Type: -

Identifier Source: org_study_id