An interventional study of Pulsed Low-Dose-Rate Radiotherapy, pLDRT in Diffuse Midline Glioma, sponsored by Centro di Riferimento Oncologico - Aviano. Recruiting at 1 site in Italy. Open to participants aged 0 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Centro di Riferimento Oncologico - Aviano · Not applicable, Interventional, and Treatment
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
Over the past decades, advances in radiation therapy technology have significantly reduced treatment-related toxicity. In patients with diffuse midline glioma (DMG), these improvements have enhanced the tolerability of radiotherapy but have not improved disease control. Pulsed low-dose-rate radiotherapy (pLDRT) may offer additional advantages by further reducing treatment-related toxicity, preserving tumor vascularization to facilitate the delivery and efficacy of subsequent chemotherapy, and exploiting the low-dose hyper-radiosensitivity phenomenon. To the best of our knowledge, no clinical studies have evaluated pLDRT in patients with DMG. Therefore, the primary objective of this phase I study is to evaluate the tolerability of pLDRT in this predominantly pediatric population and to determine a safe dose level for future clinical investigation.
Centro di Riferimento Oncologico - Aviano is the lead sponsor of 51 studies on the registry; 36 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation: Pulsed Low-Dose-Rate Radiotherapy, pLDRT
The radiotherapy treatment will preferably be delivered using volumetric modulated arc therapy (VMAT) with high-energy photons (6 MV), including 6 MV flattening filter-free (FFF) beams when appropriate. In selected cases, intensity-modulated radiotherapy (IMRT) may be used.
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale
Time frame: Up to 5 years
To evaluate the median time to local disease progression.
Median progression-free survival (PFS) defined as the time from treatment initiation to the first documented disease progression or death from any cause. Disease progression will be defined according to the RAPNO criteria for pediatric patients and the RANO criteria for adult patients.
Time frame: Up to 5 years
To evaluate median overall survival.
Median overall survival (OS), defined as the time from treatment initiation to death from any cause.
Time frame: Up to 5 years
To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
Frequency of neurological toxicities
Time frame: Up to 5 years
To assess changes in neurological symptoms compared with baseline.
Change in frequencies of neurological symptoms
Time frame: Up to 5 years
To evaluate corticosteroid use during radiotherapy.
Dexamethasone dose (mg/day) mean
Time frame: Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method
Time frame: Up to 5 years
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of circulating biomarkers will be evaluated with Kaplan-Meyer method
Time frame: Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
Relation between PFS (defined as the time from treatment initiation to the first documented disease progression or death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method
Time frame: Up to 5 years
To evaluate tissue biomarkers of response to pLDRT.
Relation between OS (defined as the time from treatment initiation to death from any cause) and levels of tissue biomarkers will be evaluated with Kaplan-Meyer method
Time frame: Up to 5 years
To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule.
Mean of median levels of biomarkers of inflammatory and immune profile
Time frame: Up to 5 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Centro di Riferimento Oncologico - Aviano