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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Elisa Coassin, MD
- Telefonnummer: +39 0434 659632
- E-mail: ecoassin@cro.it
Studiesteder
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Pordenone
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Aviano, Pordenone, Italien, 33081
- Rekruttering
- Centro di Riferimento Oncolgico -IRCCS
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Kontakt:
- Elisa Coassin
- Telefonnummer: 0434659632
- E-mail: ecoassin@cro.it
-
Ledende efterforsker:
- Elisa Coassin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Determination of the safe dose level of 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Tidsramme: Up to 5 years
|
Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale |
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To evaluate the median time to local disease progression.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: Up to 5 years
|
Frequency of neurological toxicities |
Up to 5 years
|
|
To assess changes in neurological symptoms compared with baseline.
Tidsramme: Up to 5 years
|
Change in frequencies of neurological symptoms |
Up to 5 years
|
|
To evaluate corticosteroid use during radiotherapy.
Tidsramme: Up to 5 years
|
Dexamethasone dose (mg/day) mean |
Up to 5 years
|
|
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: Up to 5 years
|
Mean of median levels of biomarkers of inflammatory and immune profile |
Up to 5 years
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CRO-2025-21
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