A Phase-1 Trial to Investigate the Use of Pulsed Low-dose Rate Radiotherapy in Diffuse Midline Gliomas. (BABY-PULSAR)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Elisa Coassin, MD
- Telefoonnummer: +39 0434 659632
- E-mail: ecoassin@cro.it
Studie Locaties
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Pordenone
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Aviano, Pordenone, Italië, 33081
- Werving
- Centro di Riferimento Oncolgico -IRCCS
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Contact:
- Elisa Coassin
- Telefoonnummer: 0434659632
- E-mail: ecoassin@cro.it
-
Hoofdonderzoeker:
- Elisa Coassin
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Radiological and/or histological diagnosis of diffuse midline glioma (DMG).
- Ability to maintain the treatment position or undergo sedation, if required.
- Written informed consent provided by the parent(s) or legal guardian(s), or by the patient if aged ≥18 years.
Exclusion Criteria:
- Refusal to undergo radiotherapy (i.e., lack of signed informed consent).
- Concurrent chemotherapy.
- Leptomeningeal dissemination of disease.
- Ongoing pregnancy (for post-pubertal female patients).
- Previous radiotherapy to the brainstem.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Tijdsspanne: Up to 5 years
|
Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale |
Up to 5 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
To evaluate the median time to local disease progression.
Tijdsspanne: Up to 5 years
|
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. |
Up to 5 years
|
|
To evaluate median overall survival.
Tijdsspanne: Up to 5 years
|
Median overall survival (OS), defined as the time from treatment initiation to death from any cause. |
Up to 5 years
|
|
To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
Tijdsspanne: Up to 5 years
|
Frequency of neurological toxicities |
Up to 5 years
|
|
To assess changes in neurological symptoms compared with baseline.
Tijdsspanne: Up to 5 years
|
Change in frequencies of neurological symptoms |
Up to 5 years
|
|
To evaluate corticosteroid use during radiotherapy.
Tijdsspanne: Up to 5 years
|
Dexamethasone dose (mg/day) mean |
Up to 5 years
|
|
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Tijdsspanne: Up to 5 years
|
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 |
Up to 5 years
|
|
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Tijdsspanne: Up to 5 years
|
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 |
Up to 5 years
|
|
To evaluate tissue biomarkers of response to pLDRT.
Tijdsspanne: Up to 5 years
|
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 |
Up to 5 years
|
|
To evaluate tissue biomarkers of response to pLDRT.
Tijdsspanne: Up to 5 years
|
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 |
Up to 5 years
|
|
To characterize the inflammatory and immune profile induced by the pLDRT treatment schedule.
Tijdsspanne: Up to 5 years
|
Mean of median levels of biomarkers of inflammatory and immune profile |
Up to 5 years
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CRO-2025-21
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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