- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07687147
Daily Adjustment of the Radiation Dose in MRI-guided Stereotactic Radiotherapy for Tumors in the Abdominal and Pelvic Regions (ACTION)
Adaptive Fractionation in Online MR-guided SBRT for Abdominal and Pelvic Target Volumes
SBRT delivers high-dose radiation to precisely defined target volumes and is an effective locally ablative treatment option for both primary tumours and oligometastases in various settings, including lesions in the abdomen or pelvis. However, SBRT in these regions faces considerable challenges such as inter-fractional organ motion and anatomical deformation, which can compromise treatment precision.
MR-guided SBRT offers a solution, providing superior soft-tissue contrast and enabling real-time, online treatment plan adaptation over the course of SBRT. This approach reduces the risk of geographical miss and overdose to adjacent, vulnerable OARs. Currently, MR-guided SBRT uses a fixed dose per fraction, only adjusting target volume and OAR contours for anatomical changes when performing plan adaptation. However, overlaps between planning target volumes (PTVs) and dose-limiting OARs regularly require compromises in PTV coverage. To address this, AF aims to also adjust dose per fraction based on daily PTV-OAR overlap. With this approach, more dose is applied on treatment days with less PTV-OAR overlap while less dose is applied on days with more PTV-OAR overlap. This trial assesses the feasibility of AF in MR-guided SBRT for abdominal and pelvic tumours that show PTV-overlap with one or more dose-limiting OARs, ultimately aiming to enhance PTV dose coverage without increasing toxicity.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jan Unkelbach, Prof. Dr. rer. nat.
- Número de teléfono: +41 44 255 85 49
- Correo electrónico: jan.unkelbach@usz.ch
Copia de seguridad de contactos de estudio
- Nombre: Lena Kretzschmar, Dr. med.
- Correo electrónico: lena.kretzschmar@usz.ch
Ubicaciones de estudio
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Canton of Zurich
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Zurich, Canton of Zurich, Suiza, 8091
- Reclutamiento
- University Hospital Zurich
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Karnofsky performance status ≥70
- Abdominal or pelvic malignancy (primary or secondary) with previous histological confirmation of the primary tumour, amenable to SBRT in 5 fractions (excluding SBRT to primary tumour in patients with prostate cancer) Note: patients with primary prostate cancer are eligible, but SBRT to the primary tumour in the prostate cannot be performed within the study
- Total prescribed SBRT dose > 30 Gy (constraint for dose-limiting OAR) over 5 treatment fractions
- Distance of the GTV ≤ 1 cm from at least one dose-limiting OAR (bowel / duodenum / stomach) in the available diagnostic images
- Patients able to tolerate long (approximately 60 minutes) treatment time according to clinical evaluation of the treating radiation oncologist
- Patients willing and able to comply with scheduled visits, treatment, and other trial procedures
Exclusion Criteria:
- Previous radiation therapy directly overlapping with planned SBRT (type I re-irradiation)
- More than one PTV irradiated in the same plan
- Contraindications for MRI, e.g., patients with metal fragments or implanted devices that are not MR compatible such as certain types of pacemakers and aneurysm clips or severe claustrophobia
- SBRT not indicated or not possible
- Inability to follow the procedures of the trial, e.g. due to language problems of the participant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: RT with AF
Patients with PTV/OAR overlap will receive AF, with dose adapted daily based on anatomy.
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The fraction dose to the PTV will be adapted based on the volume overlap of PTV and the dose-limiting OAR(s) (bowel / duodenum / stomach) on the planning MRI scan of the day ("geometry-of-the-day").
The treatment plan is then approved by the treating physician and independently verified according to department-internal standard.
MR-guided fraction dose adaptation will be repeated at each of the 5 fractions, until the prescribed total dose is reached.
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Comparador activo: RT without AF
Patients without PTV/OAR overlap will receive standard fractionated treatment.
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Patients that qualify for inclusion in the study but for whom AF is no viable treatment due to lacking PTV/OAR overlap in the planning scans.
These patients are treated according to clinical standard of care (SoC), i.e. without dose adaptation, and function as a control group.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of patients with successful daily dose adaptation
Periodo de tiempo: from enrollment to end of treatment at 1-2 weeks
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Proportion of patients treated with daily dose-adapted treatment, who received at least one fraction of non-uniformly fractionated treatment with expectation of a benefit in PTV-coverage of ≥ 1ccGy
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from enrollment to end of treatment at 1-2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acute treatment toxicities
Periodo de tiempo: during treatment (1-2 weeks) and until 90 days after
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Acute treatment toxicities for all included patients measured with Common Terminology Criteria for Adverse Events
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during treatment (1-2 weeks) and until 90 days after
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Interfractional variation in PTV/OAR overlap volume
Periodo de tiempo: during treatment (1-2 weeks)
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interfractional variation in PTV/OAR overlap volume, in cc
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during treatment (1-2 weeks)
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Interfractional variation in GTV/OAR distance
Periodo de tiempo: during treatment (1-2 weeks)
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interfractional variation in GTV/OAR distance, in mm
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during treatment (1-2 weeks)
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Dosimetric difference in PTV-coverage between algorithm-based calculation and the reference plan
Periodo de tiempo: after end of treatment (2 weeks after last fraction)
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PTV coverage quantified as the area above the dose-volume-histogram curve measured in cc x Gy
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after end of treatment (2 weeks after last fraction)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Reinhardt Krcek, Dr. med., University of Zurich
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
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias pélvicas
- Neoplasias Abdominales
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Terapéutica
- Procedimientos quirúrgicos, operativo
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Radioterapia
- Técnicas estereotáxicas
- Procedimientos neurociruúrgicos
- Estándar de cuidado
- Radiocirugía
Otros números de identificación del estudio
- RAO-25-019
- 2026-00067 (Otro identificador: BASEC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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