Clinical trial · Interventional
Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
A Phase-2 Trial to Investigate the Use of Pulsed Low-dose Rate Re-irradiation for Recurrent Glioma (PULSAR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pulsed low dose-rate radiotherapy (pLDRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pulsed low dose-rate radiotherapy (pLDRT)
- interventionNames
- Radiation: Pulsed low dose-rate radiotherapy (pLDRT)
Primary outcomes (1)
- measure
- To evaluate the incidence of brain radionecrosis in patients undergoing re-irradiation of brain tumors with pulsed low-dose-rate schedule
- timeFrame
- up to 5 years
- description
- 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 (7)
- measure
- To assess the median time to local disease progression
- timeFrame
- up to 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available