- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02454673
Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer
Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Navarra
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Pamplona, Navarra, España, 31008
- Clinica Universidad de Navarra
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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
Patients with locally advanced adenocarcinoma gastric cancer for a neoadjuvant protocol consisting of preoperative chemotherapy or induction chemotherapy, chemoradiotherapy and salvage surgery. Patients must have a medically fit condition to complete the protocol.
Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and renal function.
Radiological and endoscopic evaluations are performed at baseline and at the completion of chemotherapy and chemoradiotherapy.
Blood tests are acquired at baseline, before each chemotherapy course and concurrently with evaluations. Blood tests are also obtained during follow-up and at the time progression.
Descripción
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
- Age ≥18 years old
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Body mass index ≥ 18
- No prior chemotherapy or chemoradiotherapy
- TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
- No evidence of metastasis (M0)
- Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)
Exclusion Criteria:
- Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
- Patients with evidence of severe or uncontrolled systemic disease
- Medically unfit for chemotherapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Group A
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Group B
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Overall Survival
Periodo de tiempo: From date of diagnosis until death, assessed up to 10 years
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Overall survival was defined as the period from diagnosis until death (from any cause).
Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
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From date of diagnosis until death, assessed up to 10 years
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Disease Free Survival
Periodo de tiempo: From date of diagnosis until treatment failure, assessed up to 10 years
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DFS was defined as the time from diagnosis to the first date of local or distant cancer.
Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).
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From date of diagnosis until treatment failure, assessed up to 10 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pathological Response at the Time of Surgery
Periodo de tiempo: Weeks 10 to 28
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Specimen analysis according to TNM classification.
Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
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Weeks 10 to 28
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R0 Resection rate at the Time of Surgery
Periodo de tiempo: Weeks 10 to 28
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The R0 resection rate after the neoadjuvant protocol.
R0 is defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
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Weeks 10 to 28
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Tumor Regression Grade at the Time of Surgery
Periodo de tiempo: Weeks 10 to 28
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Estimate of tumor regression grade at the time of surgery according to Becker Criteria: Grade 1a, No residual tumor; Grade 1b, <10% residual tumor; Grade 2, 10-50% residual tumor; Grade 3, >50% residual tumor.
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Weeks 10 to 28
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Lymph nodes response at the Time of Surgery
Periodo de tiempo: Weeks 10 to 28
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Participants were assessed for node-negative lymph nodes at the time of surgery according to TNM classification.
Node-negative (pN0) participants had no regional lymph node metastasis.
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Weeks 10 to 28
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Estimate of TN Change From Baseline to Surgery
Periodo de tiempo: Weeks 10 to 28
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Estimate of TN change due to neoadjuvant treatment is defined as the estimate of the evidence of downstaging between baseline and surgery
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Weeks 10 to 28
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Javier Rodriguez Rodriguez, MD, PhD, Clinica Universidad de Navarra
Publicaciones y enlaces útiles
Publicaciones Generales
- Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
- Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.
- Xiong BH, Cheng Y, Ma L, Zhang CQ. An updated meta-analysis of randomized controlled trial assessing the effect of neoadjuvant chemotherapy in advanced gastric cancer. Cancer Invest. 2014 Jul;32(6):272-84. doi: 10.3109/07357907.2014.911877. Epub 2014 May 6.
- Carton E, Caldwell MT, McDonald G, Rama D, Tanner WA, Reynolds JV. Specialized intestinal metaplasia in patients with gastro-oesophageal reflux disease. Br J Surg. 2000 Jan;87(1):116-21. doi: 10.1046/j.1365-2168.2000.01322.x.
- Moehler M, Baltin CT, Ebert M, Fischbach W, Gockel I, Grenacher L, Holscher AH, Lordick F, Malfertheiner P, Messmann H, Meyer HJ, Palmqvist A, Rocken C, Schuhmacher C, Stahl M, Stuschke M, Vieth M, Wittekind C, Wagner D, Monig SP. International comparison of the German evidence-based S3-guidelines on the diagnosis and multimodal treatment of early and locally advanced gastric cancer, including adenocarcinoma of the lower esophagus. Gastric Cancer. 2015 Jul;18(3):550-63. doi: 10.1007/s10120-014-0403-x. Epub 2014 Sep 7.
- Lee S, Oh SY, Kim SH, Lee JH, Kim MC, Kim KH, Kim HJ. Prognostic significance of neutrophil lymphocyte ratio and platelet lymphocyte ratio in advanced gastric cancer patients treated with FOLFOX chemotherapy. BMC Cancer. 2013 Jul 22;13:350. doi: 10.1186/1471-2407-13-350.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CUN-GCNMEM
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