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

NCT06055517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-09-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Centro di Riferimento Oncologico - Aviano

    lead OTHER

Principal Investigators

  • Lorenzo Vinante, MD · Centro di Riferimento Oncologico di Aviano (CRO)

  • Lorena Baboci, PhD · Centro di Riferimento Oncologico di Aviano (CRO)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-26
Primary Completion
2028-05-26
Completion
2028-05-26

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06055517 on ClinicalTrials.gov