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NCT Number: NCT06055517

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.

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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano

Aviano, Pordenone, 33081, Italy

Location status: Recruiting

Location contact

Lorenzo Vinante, MD

CONTACT

[email protected]

+390434659855

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulsed low dose-rate radiotherapy (pLDRT)

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lorenzo Vinante, MD

CONTACT

[email protected]

0434659855

Sponsors and collaborators

Lead sponsor

Centro di Riferimento Oncologico - Aviano

Other

Registry information

Official study title

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

Acronym: PULSAR

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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