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IA Trial Radar
El ensayo clínico NCT07501845 para Cáncer rectal está aún no recluta. 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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Registry Maastro Applicator 999

Aún no recluta
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 NCT07501845 es un estudio observacional para Cáncer rectal. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 15 de marzo de 2026 hasta completar 999 participantes. Dirigido por Maastricht Radiation Oncology, se espera que finalice el 31 de diciembre de 2034. Los datos se actualizaron por última vez en ClinicalTrials.gov el 30 de marzo de 2026.
Resumen
This registry will collect data from all patients treated with the MAASTRO HDR applicator. The goal is to deepen knowledge about dose-response relationships in rectal cancer boosting, which is essential for improving future treatment approaches and patient selection.
Descripción detallada
Standard treatment for rectal cancer usually involves surgical removal of the tumor. Depending on the tumor's characteristics, patients may first receive neoadjuvant therapy such as radiotherapy, chemoradiotherapy, or total neoadjuvant treatment (TNT). These treatments aim to improve oncological outcomes and can lead to a complete response (CR) in about 10-40% of patients. When a CR occurs, patients may choose a watc...Mostrar más
Título oficial

Prospective Data Collection Initiative on MAASTRO HDR Rectal Applicator Treatments - a Prospective Observational Cohort Study.

Condiciones médicas
Cáncer rectal
Otros ID del estudio
  • Registry Maastro Applicator
Número del NCT
NCT07501845
Inicio del estudio (real)
2026-03-15
Última actualización
2026-03-30
Fecha de finalización (estimada)
2034-12-31
Inscripción (prevista)
999
Tipo de estudio
Observacional
Estado general
Aún no recluta
Palabras clave
rectal cancer
HDR Brachy
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
Patients being treated with the MAASTRO HDR rectal applicator
Treatment with the MAASTRO HDR rectal applicator
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Efficacy of Maastro applicator endoluminal HDR contact brachytherapy boosting in functional organ sparing of the rectum.
Number of patients with clinical complete respons. Number of patients with treatment related adverse events as assessed by CTCAE v 4.0
From enrollment to the end of FU at 10 years
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
Percentage of planned interventional Maastro procedures that could be conducted successfully from a procedural point of view.
During treatment
Duration of the application procedure.
Duration of the application procedure.
During treatment
Clinical complete response rate up to 5 years after treatment.
Clinical complete response rate up to 5 years after treatment.
From end of treatment until 5 years after treatment
Toxcity up to 3 year after treatment
Rectal and genitourinary toxicity scored according to CTCAE v. 5 up to 3 years after treatment
From start treatment until 3 years after the end of treatment
Disease status up to 10 years after treatment
Local and locolregional recurrence rate and metastatic rate up to 10 years after treatment
from enrollment until 10 years after treatment
Salvage surgery
Salvage surgery rate after treatment.
From end of treatment until 5 years after treatment
Overall and disease specific survival rate
Overall and disease specific survival rate up to 10 year after treatment.
from enrollment until 10 years after treatment
Discomfort/pain
Discomfort/pain during endorectal irradiation using NRS (Numeric Rating Scale 0-10) painscore
From baseline up to 2 weeks after last fraction
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Health status
Separate informed consent will be asked to measure the health status and quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30) , QLQ-CR29 ( EORTC Quality of Life Questionaires ColoRectal 29 and EQ-5D ( EuroQoL-5D)
From enrollment until 5 years after treatment
Long-term rectal functional outcome
Separate informed consent will be asked to measure the Long-term rectal functional outcome by LARS score (Low Anterior Resection Syndrome - scale 0-42)
From enrollment until 5 years after treatment
Quality of life questionnaires
Separate informed consent will be asked to measure the quality of life by QLQ-C30 ( EORTC Quality of Life Questionaires, Core 30).
From enrollment until 5 years after treatment
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  • Age ≥ 18 years.
  • Histological proof of rectal cancer, or a strong suspicion after imaging.
  • Treatment with MAASTRO HDR rectal applicator
  • Informed consent for longitudinal observational data collection.

  • Mentally incompetent patients.
Maastricht Radiation Oncology logoMaastricht Radiation Oncology
Contactos centrales del estudio
Contacto: Ann Claessens, +31 88 44 55 600, [email protected]
Sitio no especificado.