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El ensayo clínico NCT05871307 (Radcav) para Metástasis Cerebrales, Radioterapia está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases (Radcav) Fase II 90
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05871307 (Radcav) está diseñado para estudiar el tratamiento de Metástasis Cerebrales, Radioterapia. Es un estudio intervencionista de Fase II. Su estado actual es: reclutando. El estudio se inició el 1 de febrero de 2024, con el objetivo de reclutar a 90 participantes. Dirigido por University Hospital Heidelberg, se espera que finalice el 1 de mayo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 8 de mayo de 2024.
Resumen
Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life.
Combining surgery and radiotherapy for resectable brain metastases is standard of care but there is a lot of controversy on which kind of radiotherapy is best suitable. Recently, first volumetric in-silico analyses point to theoretical advantages of neoadjuvant stereotactic ...
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This trial approach allows for detailed comparison of resected tissue samples, cerebrospinal fluid and blood of all patient groups. So, the investigators will investigate biomaterial of recently irradiated (neoadjuvant and intraoperative arms) and non-irradiated (adjuvant arm) tissue. All this prompts the main issues of the explorative randomized controlled phase 2 RADCAV trial: Is there a difference between neoadjuv...Mostrar más
Título oficial
Neoadjuvant vs. Intraoperative vs. Adjuvant Resection Cavity Radiotherapy of Brain Metastases - A Prospective Randomized Explorative Phase II Trial
Condiciones médicas
Metástasis CerebralesRadioterapiaOtros ID del estudio
- Radcav
- RADOnk-Radcav
Número del NCT
Inicio del estudio (real)
2024-02-01
Última actualización
2024-05-08
Fecha de finalización (estimada)
2028-05-01
Inscripción (prevista)
90
Tipo de estudio
Intervencionista
FASE
Fase II
Estado general
Reclutando
Palabras clave
Brain Metastases
Radiotherapy
Radiotherapy
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalExperimental Arm A (Preoperativ SRS) Preoperative stereotatic radiosurgery following resection of brain metastases after 1-7 days | Radioterapia preoperatoria Resection of brain mestases following |
ExperimentalExperimental Arm B (Intraoperativ SRS) Intraoperative stereotactic radiotherapy after resection of brain metastases | Intraoperative Radiation While Resection |
Comparador activoStandard Treatment Arm C (Posoperativ SRS) Resection of brain metastases following stereotactic radiotherapy after 2-6 weeks | radioterapia postoperatoria After resection |
Resultado primario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Assessment of treatment response | number of patients without progresion according to RANO-BM | through study completion, an avarage of 60 month |
local tumor control | events of tumor progression or recurrence in the area of 1cm surrounding the resection cavity and surrounding the surgical access | through study completion, an avarage of 60 month |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Histologically confirmed solid malignancy
- Metastatic brain disease (1-10 brain metastases), with at least one brain metastasis in a non-eloquent location (i.e. motor or speech) planned for resection
- Maximum size of the brain metastasis <5cm
- Eligibility of patients for both stereotactic radiotherapy and resection
- Time interval from resection to adjuvant stereotactic radiosurgery of 2-6 weeks
- Time interval from neoadjuvant stereotactic radiosurgery to resection of 1-7 days
- Possibility to postpone resection for neoadjuvant stereotactic radiosurgery, if applicable
- Karnofsky performance scores >= 70 or Eastern Cooperative Oncology Group (ECOG) >= 2 at enrollment
- Age ≥ 18 years of age
- For women with childbearing potential, (and men) adequate contraception.
- Ability of subject to understand character and individual consequences of the clinical trial
- Written informed consent (must be available before enrolment in the trial)
Necessity of immediate surgical resection due to life threatening symptoms
- brain metastasis directly located (≤10mm) next to the optic system or brain stem
- Refusal of the patients to take part in the study
- Small-cell lung cancer (SCLC) or hematologic malignancy as primary malignant illness
- Leptomeningeal disease suspected RadCav Trial Protocol Version 1.1, 01.07.2022 18
- Previous radiotherapy of the brain
- Contraindication for contrast-enhanced MRI
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials, respectively
University Hospital HeidelbergParte responsable del estudio
Juergen Debus, Investigador principal, Department Director, University Hospital Heidelberg
Contactos centrales del estudio
Contacto: Tanja Eichkorn, MD, 06221 56, [email protected]
Contacto: Adriane Hommertgen, PhD, 06221 56, [email protected]
1 Centros del estudio en 1 países
Department of Radiotherapy, University of Heidelberg, Heidelberg, 69120, Germany
Juergen Debus, Prof. Dr. Dr., Contacto, +49 6221 56, [email protected]
Adriane Hommertgen, Dr. med., Contacto, 0622156, [email protected]
Reclutando