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

September 20, 2023 updated by: Centro di Riferimento Oncologico - Aviano

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Pordenone
      • Aviano, Pordenone, Italy, 33081
        • Recruiting
        • IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulsed low dose-rate radiotherapy (pLDRT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
Time Frame: up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the median time to local disease progression
Time Frame: up to 5 years
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
To assess the median survival time
Time Frame: up to 5 years
Assessment of median survival time. Survival will be defined as the time from study enrollment until death for any cause
up to 5 years
To assess the incidence of toxicities other than radionecrosis
Time Frame: up to 5 years
Assessment of incidence of other neurological toxicities graded with the scale CTCAE v 5.0
up to 5 years
To assess the presence of biomarkers associated with the actinic toxicity
Time Frame: up to 5 years
Frequency of selected circulating biomarkers in patients with actinic toxicity
up to 5 years
To assess the presence of biomarkers associated with response to therapy
Time Frame: up to 5 years
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
To assess the presence of biomarkers associated with overall survival (OS)
Time Frame: up to 5 years
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
To evaluate the immunomodulation induced by the pulsed schedule in comparison with the conventional schedule
Time Frame: up to 5 years
Difference in the frequency of immunotherapeuthic markers between pulsed and conventional radiotherapy schedules
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro di Riferimento Oncologico - Aviano

Investigators

  • Principal Investigator: Lorenzo Vinante, MD, Centro di Riferimento Oncologico di Aviano (CRO)
  • Principal Investigator: Lorena Baboci, PhD, Centro di Riferimento Oncologico di Aviano (CRO)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2023

Primary Completion (Estimated)

May 26, 2028

Study Completion (Estimated)

May 26, 2028

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2022-82

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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