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

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ClinicalTrials.gov Identifier: NCT06055517
Recruitment Status : Recruiting
First Posted : September 26, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Centro di Riferimento Oncologico - Aviano

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.

Condition or disease Intervention/treatment Phase
Glioma Radiation: Pulsed low dose-rate radiotherapy (pLDRT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
Actual Study Start Date : May 26, 2023
Estimated Primary Completion Date : May 26, 2028
Estimated Study Completion Date : May 26, 2028

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055517


Contacts
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Contact: Lorenzo Vinante, MD 0434659855 lorenzo.vinante@cro.it

Locations
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Italy
IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano Recruiting
Aviano, Pordenone, Italy, 33081
Contact: Lorenzo Vinante, MD    +390434659855    lorenzo.vinante@cro.it   
Sponsors and Collaborators
Centro di Riferimento Oncologico - Aviano
Investigators
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Principal Investigator: Lorenzo Vinante, MD Centro di Riferimento Oncologico di Aviano (CRO)
Principal Investigator: Lorena Baboci, PhD Centro di Riferimento Oncologico di Aviano (CRO)
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Responsible Party: Centro di Riferimento Oncologico - Aviano
ClinicalTrials.gov Identifier: NCT06055517    
Other Study ID Numbers: CRO-2022-82
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue