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El ensayo clínico NCT07324798 (SMART-B01) para Prostate Cancer (Post Prostatectomy), Cáncer de vejiga 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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Adaptive Radiotherapy for Genitourinary Cancers (SMART-B01) 60 Diseño adaptativo
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 NCT07324798 (SMART-B01) es un estudio intervencionista para Prostate Cancer (Post Prostatectomy), Cáncer de vejiga. Su estado actual es: reclutando. El estudio se inició el 1 de diciembre de 2024, con el objetivo de reclutar a 60 participantes. Dirigido por Cancer Institute and Hospital, Chinese Academy of Medical Sciences, se espera que finalice el 31 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 7 de enero de 2026.
Resumen
The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are:
Does adaptive boost lower the toxicities? Does ada...
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Prospective Study of siMultaneous Adaptive RadioTherapy for Local Boost for Prostate and Bladder Cancers (SMART-B01)
Condiciones médicas
Prostate Cancer (Post Prostatectomy)Cáncer de vejigaOtros ID del estudio
- SMART-B01
- NCC-020503
Número del NCT
Inicio del estudio (real)
2024-12-01
Última actualización
2026-01-07
Fecha de finalización (estimada)
2028-12-31
Inscripción (prevista)
60
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
prostate cancer
bladder cancer
adaptive radiotherapy
post-prostatectomy
bladder-conserving treatment
bladder cancer
adaptive radiotherapy
post-prostatectomy
bladder-conserving treatment
Objetivo principal
Tratamiento
Método de asignación
N/A
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalExperimental arm Pts will receive adaptive boost for clinically significant disease | adaptive RT Prostate cancer pts post-prostatectomy：95%PTVboost 7Gy/3.5Gy/2f，95%PTV 66Gy/2.0Gy/33f，w/o 95%PTVp 50Gy/2.0Gy/25f Bladder cancer pts with bladder-conserving txt：95%PGTV 18Gy/6.0Gy/3f，95%PTV 50Gy/2.0Gy/25f，w/o 95%PTVp 50Gy/2.0Gy/25f |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT | 3-months post-RT |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Quality-of-Life, general | general quality-of-life questionaaires as per EORTC QLQ-C30 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Local control | local control | 2-year |
disease-free survival | disease-free survival | 2-year |
Late toxicities | Late GU and GI toxicities as per RTOG scales | 2-year |
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | GU quality-of-life questionaaires as per EORTC QLQ-NMIBC24 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per EORTC QLQ- BLM30 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per BCI | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per FACT-BL | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per FACT-P | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per EPIC-26 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Quality-of-Life, sexual scales | quality-of-life questionaaires as per IIEF-5 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Hombre
- Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy;
- Age ≥ 18 years;
- ECOG performance status score 0-2;
- No prior radiotherapy history within the current radiation field;
- No contraindications for MRI scanning;
- No contraindications for radiotherapy.
- Patients with contraindications to radiotherapy;
- Patients unable to tolerate MRI or with contraindications to MRI scanning.
Cancer Institute and Hospital, Chinese Academy of Medical SciencesParte responsable del estudio
NINGNING LU, Investigador principal, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contactos centrales del estudio
Contacto: Ning-Ning Lu, M.D., 861018611804268, [email protected]
1 Centros del estudio en 1 países
Beijing Municipality
Cancer Hospital, National Cancer Center, CAMS & PUMC, Beijing, Beijing Municipality, 100021, China
Ning-Ning Lu, M.D., Contacto, 861018611804268, [email protected]
Reclutando