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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Elisa Coassin, MD
- Telefonnummer: +39 0434 659632
- E-Mail: ecoassin@cro.it
Studienorte
-
-
Pordenone
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Aviano, Pordenone, Italien, 33081
- Rekrutierung
- Centro di Riferimento Oncolgico -IRCCS
-
Kontakt:
- Elisa Coassin
- Telefonnummer: 0434659632
- E-Mail: ecoassin@cro.it
-
Hauptermittler:
- Elisa Coassin
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Zeitfenster: Up to 5 years
|
Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale |
Up to 5 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
To evaluate the median time to local disease progression.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: Up to 5 years
|
Frequency of neurological toxicities |
Up to 5 years
|
|
To assess changes in neurological symptoms compared with baseline.
Zeitfenster: Up to 5 years
|
Change in frequencies of neurological symptoms |
Up to 5 years
|
|
To evaluate corticosteroid use during radiotherapy.
Zeitfenster: Up to 5 years
|
Dexamethasone dose (mg/day) mean |
Up to 5 years
|
|
To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: Up to 5 years
|
Mean of median levels of biomarkers of inflammatory and immune profile |
Up to 5 years
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CRO-2025-21
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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