- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01740375
Role of Esophagectomy in Complete Responders to CCRT (ESOPRESSO)
26 de agosto de 2017 actualizado por: Sung-Bae Kim, Asan Medical Center
A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Squamous Cell Carcinoma of Esophagus
To investigate the role of esophagectomy in complete responders to preoperative chemoradiotherapy for squamous cell carcinoma of esophagus, patients will be randomized to either observation or esophagectomy after concurrent chemoradiotherapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
After completion of concurrent chemoradiotherapy, patients will be reassed and visited to multidisciplinary clinic, then, randomized to either observation or esophagectomy.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
486
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Seoul, Corea, república de, 05505
- Asan Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Histologically proven squamous cell carcinoma of the intrathoracic esophagus
- Surgically resectable (cT3, cT4a and/or disease with lymph node metastasis by AJCC 7th ed) esophageal cancer, as determined by Endoscopic Ultra Sound (EUS), chest CT and PET-CT
- No prior treatment for the esophageal cancer
- Age: 20-70 years
- ECOG performance status 0, 1 or 2
- Adequate hematological, renal, hepatic, pulmonary and cardiac functions defined as 6.1 Granulocytes > 1,500/microliter, Platelets > 75,000/microliter 6.2 Creatinine < 1.5 mg/dL (or CCr> 50 mg/mL), 6.3 Total bilirubin < 1.5 mg/dL 6.4 ALT and AST < 2.5 × upper normal limit 6.5 FEV1 >=1.5 L/min 6.6 Ejection fraction >= 45%
- Non-pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy
- Written, voluntary informed consent
Exclusion Criteria:
- Subtypes other than squamous cell carcinoma
- cT1N0M0, cT2N0M0 esophageal cancer or in situ carcinoma
- Invasion of recurrent laryngeal, phrenic or sympathetic nerve
- Invasion of the tracheobronchial tree or presence of tracheoesophageal fistula
- Invasion of major vessels (vena cava, azygos vein and aorta) by the tumor
- Malignant pleural effusion (documented by cytospin or cytology)
- Cervical esophageal cancer
- Para-aortic lymph node metastasis
- Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, curatively treated carcinoma in situ of the cervix, curatively treated early gastric cancer with endoscopic mucosal resection or a cured malignancy more than 5 years prior to enrollment
- Previous chemotherapy or prior history of radiotherapy interfering with the planned radiotherapy as per protocol
- Patients with a known history of HIV seropositivity or HCV (+). Patients with HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine, etc) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
- Other serious illness or medical conditions A. Unstable cardiac disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease) despite treatment, myocardial infarction within 6 months prior to study entry B. History of significant neurologic or psychiatric disorders including dementia or seizures C. Active uncontrolled infection (viral, bacterial or fungal infection) D. Other serious medical illnesses
- New York heart Association Class III/IV and history of active angina. Documented myocardial infarction within the 6 months preceding registration. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. History of 2nd or 3rd degree heart blocks.
- Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Uncontrolled diabetes mellitus: fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control; fasting glucose >150 mg/dL or patients requiring insulin therapy for glycemic control;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
|
Sin intervención: Arm B: observation:
No additional treatment after concurrent chemoradiotherapy.
However, esophagectomy will be considered as a salvage treatment for local recurrence during observation.
|
|
|
Experimental: Arm A: esophagectomy
Esophagectomy will be performed preferentially within 8 weeks (maximum 12 weeks) after completion of concurrent chemoradiotherapy
|
esofagectomía
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
2-year disease-free survival (DFS) rate
Periodo de tiempo: 2 years from the enrollment of last patient
|
2 years from the enrollment of last patient
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Overall survival (OS)
Periodo de tiempo: 5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
progression-free survival
Periodo de tiempo: 5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
failure pattern
Periodo de tiempo: 5 years from the enrollment of last patient
|
5 years from the enrollment of last patient
|
|
Number of Participants with Adverse Events
Periodo de tiempo: up to 60 days after treatment
|
up to 60 days after treatment
|
|
Comparison of clinical complete response (cCR) vs. pathologic complete response rate (pCR) in patients who underwent esophagectomy
Periodo de tiempo: 5 years
|
5 years
|
|
Comparison of OS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of OS according to metabolic response after induction chemotherapy
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Quality of life
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of PFS according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of TTF according to clinical response (CR vs PR vs SD/PD) after preoperative chemoradiotherapy among those who underwent preplanned esophagectomy;
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of PFS according to metabolic response after induction chemotherapy
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
Comparison of TTF according to metabolic response after induction chemotherapy
Periodo de tiempo: 5 years from the enrollment of the last patient
|
5 years from the enrollment of the last patient
|
|
treatment-related mortality
Periodo de tiempo: up to 60 days after completion of treatment
|
up to 60 days after completion of treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2012
Finalización primaria (Actual)
1 de enero de 2017
Finalización del estudio (Actual)
1 de enero de 2017
Fechas de registro del estudio
Enviado por primera vez
27 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
30 de noviembre de 2012
Publicado por primera vez (Estimar)
4 de diciembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
29 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias de Cabeza y Cuello
- Enfermedades esofágicas
- Neoplasias De Células Escamosas
- Neoplasias Esofágicas
- Carcinoma
- Carcinoma De Células Escamosas
- Carcinoma de células escamosas de esófago
Otros números de identificación del estudio
- Esophageal cancer AMC02
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. .