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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elisa Coassin, MD
- Número de teléfono: +39 0434 659632
- Correo electrónico: ecoassin@cro.it
Ubicaciones de estudio
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Pordenone
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Aviano, Pordenone, Italia, 33081
- Reclutamiento
- Centro di Riferimento Oncolgico -IRCCS
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Contacto:
- Elisa Coassin
- Número de teléfono: 0434659632
- Correo electrónico: ecoassin@cro.it
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Investigador principal:
- Elisa Coassin
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Determination of the safe dose level of pulsed low-dose-rate radiotherapy (pLDRT)
Periodo de tiempo: Up to 5 years
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Incidence of grade ≥3 toxicities, as defined according to the CTCAE v5.0 scale |
Up to 5 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To evaluate the median time to local disease progression.
Periodo de tiempo: Up to 5 years
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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
|
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To evaluate median overall survival.
Periodo de tiempo: Up to 5 years
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Median overall survival (OS), defined as the time from treatment initiation to death from any cause. |
Up to 5 years
|
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To assess the incidence of treatment-related toxicities other than dose-limiting toxicities.
Periodo de tiempo: Up to 5 years
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Frequency of neurological toxicities |
Up to 5 years
|
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To assess changes in neurological symptoms compared with baseline.
Periodo de tiempo: Up to 5 years
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Change in frequencies of neurological symptoms |
Up to 5 years
|
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To evaluate corticosteroid use during radiotherapy.
Periodo de tiempo: Up to 5 years
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Dexamethasone dose (mg/day) mean |
Up to 5 years
|
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To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Periodo de tiempo: Up to 5 years
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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
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To evaluate circulating prognostic and predictive biomarkers of response to pLDRT.
Periodo de tiempo: Up to 5 years
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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
|
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To evaluate tissue biomarkers of response to pLDRT.
Periodo de tiempo: Up to 5 years
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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.
Periodo de tiempo: Up to 5 years
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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.
Periodo de tiempo: Up to 5 years
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Mean of median levels of biomarkers of inflammatory and immune profile |
Up to 5 years
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRO-2025-21
Información sobre medicamentos y dispositivos, documentos del estudio
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