Nefroureterectomía con y sin disección de ganglios linfáticos para el carcinoma de células uroteliales del tracto superior
Ensayo controlado aleatorio que examina los resultados oncológicos y perioperatorios de la nefroureterectomía con y sin disección de ganglios linfáticos para el carcinoma de células uroteliales del tracto superior
The goal of this study is to conduct the first randomized-controlled trial to determine the oncologic efficacy of lymph node dissection in participants with upper tract urothelial cell carcinoma. The main questions it aims to answer are:
- To determine oncologic outcomes, specifically 2-year recurrence-free survival
- To determine other oncologic outcomes including treatment-free, cancer-specific and overall survival
- To determine time to recurrence and recurrence patterns
- To determine use of adjuvant therapies
- To determine perioperative complications
Participants will undergo nephroureterectomy with or without lymph node dissection. Researchers will compare these two groups to determine the oncologic efficacy of performing lymph node dissection.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Upper Tract Urothelial Carcinoma (UTUC) is a rare disease with complex management. Some participants with clinically negative nodes may still receive a lymph node dissection (LND) with nephroureterectomy, and currently, no randomized controlled trial exists to evaluate the oncologic efficacy of this practice. According to current American Urologic Association guidelines, Nephroureterectomy is the standard of care intervention for high-risk UTUC and low-risk UTUC is endoscopically unresectable. The aim of the present study is to determine the efficacy, specifically 2-year recurrence-free survival, of lymph node dissection at time of nephroureterectomy for participants with UTUC, compared to no lymph node dissection, as well as examine other oncologic outcomes and complication rates
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohamed Eltemamy, MD
- Número de teléfono: 216-444-5888
- Correo electrónico: Eltemam@ccf.org
Copia de seguridad de contactos de estudio
- Nombre: Rebecca Campbell, MD
- Número de teléfono: 216-444-1105
- Correo electrónico: CAMPBER7@ccf.org
Ubicaciones de estudio
-
-
Florida
-
Gainesville, Florida, Estados Unidos, 32209
- Reclutamiento
- University of Florida Health Science Center
-
Contacto:
- Tarik Benidir, MD
-
Sub-Investigador:
- Tarik Benidir, MD
-
-
Illinois
-
Springfield, Illinois, Estados Unidos, 62702
- Reclutamiento
- Southern Illinois University
-
Contacto:
- Mohammad Mahmoud, MD
- Correo electrónico: mmahmoud96@siumed.edu
-
Investigador principal:
- Mohammad Mahmoud, MD
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Reclutamiento
- Cleveland Clinic Glickman Urological and Kidney Institute
-
Contacto:
- Mohamed Eltemamy, MD
- Número de teléfono: 216-444-5888
- Correo electrónico: Eltemam@ccf.org
-
Cleveland, Ohio, Estados Unidos, 44106
- Reclutamiento
- University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
-
Contacto:
- Adam Calaway, MD, MPH
- Correo electrónico: Adam.Calaway@UHhospitals.org
-
Investigador principal:
- Adam Calaway, MD, MPH
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults > 18 years
- Diagnosis of UTUC as determined by upper tract biopsy (either low or high grade)
- Planned for nephroureterectomy by their urologic surgeon
- Disease that is ≤cT4, N0M0. Participants must have complete TNM staging prior to surgery. cT disease can be determined by biopsy of the mass (if biopsy was deep enough) or imaging (CT/MRI). cN and cM stage must be determined by preoperative imaging of the chest, abdomen and pelvis.
- No concomitant muscle-invasive bladder cancer
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Pathologically enlarged lymph nodes suspicious for metastases which would require lymph node dissection regardless of trial (>cN0)
- Presence of distant metastases
- Concomitant muscle invasive bladder cancer
- The participant is in a reduced general condition or has a life-threatening disease.
- The participant has a psychiatric disorder that precludes them from understanding the consent process.
- The patient is pregnant
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Nephroureterectomy With Lymph Node Dissection
Participants will undergo nephroureterectomy for UTUC and will receive LND. |
Participants will undergo standard-of-care nephroureterectomy for UTUC. Participants will receive lymph node dissection alongside nephroureterectomy for UTUC. |
|
Comparador activo: Nephroureterectomy Without Lymph Node Dissection
Participants will undergo nephroureterectomy for UTUC and will not receive LND. |
Participants will undergo standard-of-care nephroureterectomy for UTUC. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recurrence-free survival
Periodo de tiempo: 2 years post-op
|
Kaplan-Meier will compare recurrence-free survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Treatment-free survival
Periodo de tiempo: 2 years post-op
|
Kaplan-Meier will compare treatment-free survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Cancer-specific survival
Periodo de tiempo: 2 years post-op
|
Kaplan-Meier will compare cancer-specific survival time between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Overall Survival
Periodo de tiempo: 2 years post-op
|
Kaplan-Meier will compare the overall survival between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Time to recurrence
Periodo de tiempo: 2 years post-op
|
Kaplan-Meier will compare the time to disease recurrence between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Use of adjuvant therapies
Periodo de tiempo: 2 years post-op
|
T-test or the Wilcoxon rank-sum test will be applied to determine the rate of adjuvant therapies used between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
|
Perioperative complications
Periodo de tiempo: 2 years post-op
|
T-test or the Wilcoxon rank-sum test will be applied to determine the rate of perioperative complications between participants who received LND vs participants who did not receive LND. |
2 years post-op
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohamed Eltemamy, MD, Cleveland Clinic, Glickman Urological and Kidney Institute, Case Comprehensive Cancer Center
- Investigador principal: Adam Calaway, MD, MPH, University Hospitals Cleveland Medical Center, Urology Institute, Case Comprehensive Cancer Center
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
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Carcinoma
- Carcinoma De Células De Transición
- Procedimientos quirúrgicos, operativo
- Procedimientos quirúrgicos urológicos
- Procedimientos quirúrgicos urogenitales
- Nefrectomía
- Escisión de ganglios linfáticos
- Nefrureterectomía
Otros números de identificación del estudio
- CASE2824
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
This will be shared via a redcap database. All of the variables listed in the PRMC protocol and IRB application will be shared.
Marco de tiempo para compartir IPD
From when the trial starts (receives IRB approval and recruitment is initiated) until 1 year after the final participant finishes 2 year follow-up.
Criterios de acceso compartido de IPD
This will be shared with the following people at UH PI, research coordinator, residents/fellows/other attendings who are included on the IRB at UH.
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .