GliomaPULSARNCT06055517
Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
A study testing Pulsed low dose-rate radiotherapy (pLDRT) in people with Glioma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Pulsed low dose-rate radiotherapy (pLDRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteItaly
- Study dates
- 26 May 2023to 26 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS-Centro di Riferimento Oncologico (CRO) di Aviano
Aviano, Pordenone, 33081
Lorenzo Vinante, MD, +390434659855, lorenzo.vinante@cro.it
About this study
Official title: 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.
- Conditions
- Glioma
- Being tested
- Pulsed low dose-rate radiotherapy (pLDRT)
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed low dose-rate radiotherapy (pLDRT) | Experimental | Not described Receives: Radiation: Pulsed low dose-rate radiotherapy (pLDRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
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
Measured: up to 5 years
Secondary outcomes (7)
To assess the median time to local disease progression
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.
Measured: up to 5 years
To assess the median survival time
Assessment of median survival time. Survival will be defined as the time from study enrollment until death for any cause
Measured: up to 5 years
To assess the incidence of toxicities other than radionecrosis
Assessment of incidence of other neurological toxicities graded with the scale CTCAE v 5.0
Measured: up to 5 years
To assess the presence of biomarkers associated with the actinic toxicity
Frequency of selected circulating biomarkers in patients with actinic toxicity
Measured: up to 5 years
To assess the presence of biomarkers associated with response to therapy
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
Measured: up to 5 years
To assess the presence of biomarkers associated with overall survival (OS)
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
Measured: up to 5 years
To evaluate the immunomodulation induced by the pulsed schedule in comparison with the conventional schedule
Difference in the frequency of immunotherapeuthic markers between pulsed and conventional radiotherapy schedules
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start26 May 2023
- Primary completion26 May 2028 (estimated)
- Study completion26 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorenzo Vinante, MD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)Lorena Baboci, PhD, Principal investigator, Centro di Riferimento Oncologico di Aviano (CRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055517
- Sponsor's protocol ID
- CRO-2022-82
- Acronym
- PULSAR
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
- ClinicalTrials.gov ID
- NCT06055517
- Acronym / sponsor ID
- PULSAR / CRO-2022-82
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 26 May 2028 (estimated)
- Study completion
- 26 May 2028 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed low dose-rate radiotherapy (pLDRT) | Experimental | Radiation: Pulsed low dose-rate radiotherapy (pLDRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Pulsed low dose-rate radiotherapy (pLDRT) |
Primary outcome
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
7 secondary outcomes
To assess the median time to local disease progression
Time frame: up to 5 years
To assess the median survival time
Time frame: up to 5 years
To assess the incidence of toxicities other than radionecrosis
Time frame: up to 5 years
To assess the presence of biomarkers associated with the actinic toxicity
Time frame: up to 5 years
To assess the presence of biomarkers associated with response to therapy
Time frame: up to 5 years
To assess the presence of biomarkers associated with overall survival (OS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Vinante, MD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO)
Lorena Baboci, PhD principal investigator
Centro di Riferimento Oncologico di Aviano (CRO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed low dose-rate radiotherapy (pLDRT) in people with Glioma, run by Centro di Riferimento Oncologico - Aviano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Vinante, MD (0434659855, lorenzo.vinante@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.