Beneficios de supervivencia de la quimioterapia sistémica neoadyuvante en el cáncer de vejiga con invasión muscular (AssiutU)
Beneficio de supervivencia de la quimioterapia sistémica neoadyuvante en el cáncer de vejiga con invasión muscular y factores que afectan su respuesta: estudio retrospectivo
Muscle-invasive bladder cancer (MIBC) is an aggressive disease with a high-risk of early metastasis and cancer specific mortality. The gold standard treatment of MIBC is radical cystectomy (RC) in conjunction with concomitant bilateral pelvic lymphadenectomy . While radical cystectomy remains a primary management strategy for MIBC, high rates of recurrence with surgery alone highlight the likelihood of occult micrometastatic disease at the time of diagnosis. Due to the development and implementation of neoadjuvant chemotherapy prior to radical cystectomy, the prognosis for MIBC patients undergoing radical cystectomy has improved .
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The goals of neoadjuvant chemotherapy administration are to; eradicate the micro-metastases, avoid the release and implantation of malignant cells during cystectomy, and extend the survival of these patients.
Clinical trial data supports the use of neoadjuvant platinum-based chemotherapy for patients with non-metastatic MIBC. Based on Level I evidence, use of preoperative platinum based chemotherapy is now included in the guideline recommendations from the American Urologic Association (AUA), American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and European Association of Urology (EAU) . In the Southwest Oncology Group (SWOG) Intergroup study, RC alone was compared with three cycles of neoadjuvant MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), followed by radical cystectomy. This randomized trial showed that the median survival duration was 77 months in patients with combination treatment, and 46 months in patients with upfront RC alone.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Asyut Governorate
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Asyut, Asyut Governorate, Egipto, 71511
- Assuit universty hospitals
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Data Record of the patients will be reviewed for the following : *Clinical features:Age , Sex , Smoking ,base line renal function , comorbidities *HistoPathological features: Histological type of bladder cancer ,Carcinoma in situ,Lymphovascular invasion ( LVI)
- Type of neoadjuvant chemotherapy received: Platinum based ( cisplatin, carboplatin)
- Number of cycles .
- Response to neoadjuvant chemotherapy : Assesed by radiological tools ( MRI , CT ) according to Recist criteria.
- Follow up after finishing the course of neoadjuvant chemotherapy , using imaging and examination to detect the response and survival outcomes.
Descripción
Inclusion Criteria:
- Age >18
- histological proven MIBC patient treated with neoadjuvant systemic chemotherapy( platinum based )
Exclusion Criteria:
- Non muscle invasive bladder cancer (NMIBC)
- Metastatic patients
- Patients treated with surgery firstly
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: RETROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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MIBC patients who received NAT
muscle invasive bladder cancer patients who received neoadjuvant chemotherapy |
medical records that patients received neoadjuvant systemic chemotherapy platine based |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluating the factors affecting the response of neoadjuvant chemotherapy in muscle invasive bladder cancer
Periodo de tiempo: 3 to 6 months (from previous medical reports )
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evaluating the neoadjuvant respose by clinical examination and radiological tools ( CT , MRI ) according to Recist criteria |
3 to 6 months (from previous medical reports )
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Disease free survival (DFS)
Periodo de tiempo: thorough study completion (an average 1 year )
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DFS the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. |
thorough study completion (an average 1 year )
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overall survival (OS)
Periodo de tiempo: from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeks
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OS: defined as the length of time from either the date of diagnosis or the start of treatment for cancer, that patients are still alive. |
from the randomization until the date of 1st decument progression or death from any cause , whichever come first assesed up to 100 weeks
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Progression Free Survival ( PFS )
Periodo de tiempo: an average 2 years
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the average lenght of time after the start of treatment in which a person is alive and their cancer does not grow or spread |
an average 2 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Rehab Farouk Mohamed, Professor, Assiut University
Publicaciones y enlaces útiles
Publicaciones Generales
- Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol. 2005 Aug;48(2):202-5; discussion 205-6. doi: 10.1016/j.eururo.2005.04.006. Epub 2005 Apr 21.
- Yin M, Joshi M, Meijer RP, Glantz M, Holder S, Harvey HA, Kaag M, Fransen van de Putte EE, Horenblas S, Drabick JJ. Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer: A Systematic Review and Two-Step Meta-Analysis. Oncologist. 2016 Jun;21(6):708-15. doi: 10.1634/theoncologist.2015-0440. Epub 2016 Apr 6.
- Motterle G, Andrews JR, Morlacco A, Karnes RJ. Predicting Response to Neoadjuvant Chemotherapy in Bladder Cancer. Eur Urol Focus. 2020 Jul 15;6(4):642-649. doi: 10.1016/j.euf.2019.10.016. Epub 2019 Nov 8.
- Daneshmand S, Nazemi A. Neoadjuvant Chemotherapy in Variant Histology Bladder Cancer: Current Evidence. Eur Urol Focus. 2020 Jul 15;6(4):639-641. doi: 10.1016/j.euf.2020.04.011. Epub 2020 May 22.
- Hu J, Chen J, Ou Z, Chen H, Liu Z, Chen M, Zhang R, Yu A, Cao R, Zhang E, Guo X, Peng B, Deng D, Cheng C, Liu J, Li H, Zou Y, Deng R, Qin G, Li W, Wang L, Chen T, Pei X, Gong G, Tang J, Othmane B, Cai Z, Zhang C, Liu Z, Zu X. Neoadjuvant immunotherapy, chemotherapy, and combination therapy in muscle-invasive bladder cancer: A multi-center real-world retrospective study. Cell Rep Med. 2022 Nov 15;3(11):100785. doi: 10.1016/j.xcrm.2022.100785. Epub 2022 Oct 19.
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
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias Urológicas
- Enfermedades de la vejiga urinaria
- Neoplasias de la vejiga urinaria
- Terapéutica
- Terapia con drogas
Otros números de identificación del estudio
- Survival of NAC in MIBC
Información sobre medicamentos y dispositivos, documentos del estudio
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