Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients
10 de diciembre de 2018 actualizado por: Zefen Xiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Salvage Chemoradiation Therapy for Recurrence After Radical Surgery or Palliative Surgery in Esophageal Cancer Patients: A Prospective, Multicenter Clinical Trial
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received radical surgery.
However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months.
In patients who had residual tumor after surgery, evidence lacks for chemoradiation.
The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Currently, adjuvant therapy is not recommended for patients with esophageal squamous cell carcinoma who received surgery as their first treatment. However, the recurrence rate is as high as 23.8%-58%, and the median time-to-recurrence is about 10.5 months. In patients who had residual tumor after surgery, evidence lacks for chemoradiation.
Retrospective data of 218 cases in our hospital indicated patients underwent salvage chemoradiation had significantly improved survival compared with chemotherapy, radiotherapy or best supportive care. For patients with locoregional recurrence, the 1-, 3-year overall survival (OS) rates were statistically higher in patients received salvage chemoradiation than radiotherapy (1-year OS, 70.0% vs. 55.2%, 3-year OS, 41.9% vs. 23.5%, p=0.045). Patients received chemotherapy had 1-year OS of 0%.
Data of 218 cases of our hospital indicated patients received radiation dose > 54Gy had a significantly longer median overall survival time of 21.2 months compared with 11.3 months in patients had <54Gy. The optimal radiation dose should be further investigated.
The recurrence pattern of patients with esophageal cancer after esophagectomy mainly consist of supraclavicular and mediastinal lymph nodes. For patients recurred after radical surgery, prophylactic irradiation to high-risk lymph node regions should be considered. The study use simultaneously integrated boost (SIB) intensity-modulated radiation therapy (IMRT) in this trial, which made different radiation dose to recurrent tumor and high-risk lymph node regions possible.
The aim of the study is to evaluate the efficacy and safety of chemoradiation therapy in patients with recurrences after radical surgery or palliative surgery. Patients were further assigned to receive elective field irradiation (ENI) or involved field irradiation (IFI) according to tumor size, tumor location and time-to-recurrence.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
300
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.
Estudio Contacto
- Nombre: Lei Deng, MD
- Número de teléfono: +86-18611766429
- Correo electrónico: dengleipumc@163.com
Ubicaciones de estudio
-
-
Beijing
-
Beijing, Beijing, Porcelana, 100021
- Reclutamiento
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
-
Contacto:
- Zefen Xiao, MD
-
-
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
16 años a 70 años (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Locoregional recurrence after radical surgery;
- Positive resection margin (R1/R2) after surgery;
- Out-of-field recurrence after adjuvant chemoradiation or radiotherapy;
- Recurrence after adjuvant chemotherapy;
- No prior therapy after recurrence;
- Age 16-70 years;
- KPS>70;
- No history of drug allergy;
- Sufficient liver and kidney functions;
- White blood cell count > 4.0*10^9/L.
Exclusion Criteria:
- Age>70 or <16 years;
- Pregnancy or lactation;
- History of drug allergy;
- Declining informed consent;
- Insufficient liver or kidney functions, or abnormal CBC test;
- Severe cardiovascular diseases, infections, active ulcerations, diabetes mellitus with unstable blood sugar, mental disorders.
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: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Involved field irradiation
Patients after R0 surgery whose recurrence lesion larger than 5cm in diameter, or largest diameter was less than 5cm but with skip metastasis far from primary tumor or their time-to-recurrence longer than 16 months were assigned to involved field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 60Gy/2Gy/30f, and for lesions close to the thoracic stomach, the prescribed dose is 59.4-61.2Gy/1.8Gy/33-34f.
Chest CT scan is planned at 50Gy.
Radiation field should be modified according to the tumor response.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF (3-6mg) should be given after 48 hours of chemotherapy.If patients received postoperative chemotherapy of paclitaxel and platinum and went through local-regional recurrence within six months, it is allowed to deliver chemotherapy regimens in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
|
Involved field irradiation; intensity-modulated radiation therapy
Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
|
|
Experimental: Elective field irradiation
Patients after R1/R2 surgery or R0 surgery with the recurrence lesion whose diameter was less than 5cm without skip metastasis far from primary tumor and time-to-recurrence shorter than 16 months were assigned to elective field irradiation group.
For lesions far from the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a simultaneously integrated boost up to 59.92-62.16Gy/2.14-2.22Gy/28f.
For lesions close to the thoracic stomach, the prescribed dose is 50.4Gy/1.8Gy/28f
with a sequential boost of 10-12Gy/1.8-2Gy/5-7f.
For patients whose planned thoracic stomach V50>50%, the dose should be lowered to 45Gy/1.8Gy/25f.
Concurrent chemotherapy of paclitaxel and platinum was delivered every 3 weeks.
PEG-rhG-CSF should be given in need.
If patients received postoperative chemotherapy of TP and went through local-regional recurrence within 6 months, chemotherapy regimens delivered in the second line.
Consolidate chemotherapy were adjusted to the patients after radiation therapy.
|
Paclitaxel 135-150mg/m2, d1, every 3 weeks
for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
Elective field irradiation; intensity-modulated radiation therapy
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Supervivencia global a 1, 2 y 3 años
Periodo de tiempo: Desde el inicio del tratamiento hasta la muerte por cualquier causa o censura, evaluada hasta 36 meses
|
Sobrevivencia promedio
|
Desde el inicio del tratamiento hasta la muerte por cualquier causa o censura, evaluada hasta 36 meses
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Supervivencia libre de progresión a 1, 2 y 3 años
Periodo de tiempo: Desde el inicio del tratamiento hasta la primera progresión documentada o muerte o censura, evaluado hasta 36 meses
|
Supervivencia libre de progresión
|
Desde el inicio del tratamiento hasta la primera progresión documentada o muerte o censura, evaluado hasta 36 meses
|
|
1-, 2-, 3-year local progression-free survival
Periodo de tiempo: From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
|
Local progression-free survival
|
From treatment initiation to first documented local progression or death or censor, assessed up to 36 months
|
|
Simultaneously integrated boost radiation therapy completion rate
Periodo de tiempo: During chemoradation, assessed up to 60 days
|
Radiation therapy completion rate
|
During chemoradation, assessed up to 60 days
|
|
Toxicities according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
Periodo de tiempo: Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
|
Toxicities of chemoradiation therapy
|
Assessed within 3 months from initiation of chemoradiaiton (acute), and 3 months after initiation of chemoradiation (late), according to RTOG and CTCAE criteria, including hematological and non-hematological toxicities
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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 (Actual)
1 de noviembre de 2018
Finalización primaria (Anticipado)
31 de octubre de 2022
Finalización del estudio (Anticipado)
31 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
31 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
5 de noviembre de 2018
Publicado por primera vez (Actual)
6 de noviembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de diciembre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
10 de diciembre de 2018
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Neoplasias
- Neoplasias por sitio
- Atributos de la enfermedad
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias de Cabeza y Cuello
- Enfermedades esofágicas
- Reaparición
- Neoplasias Esofágicas
- Mecanismos moleculares de acción farmacológica
- Agentes antineoplásicos
- Moduladores de tubulina
- Agentes antimitóticos
- Moduladores de mitosis
- Agentes antineoplásicos, fitogénicos
- Paclitaxel
Otros números de identificación del estudio
- 18-175/1753
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Cáncer de esófago
-
Istanbul Aydın UniversityTerminado
-
Abramson Cancer Center of the University of PennsylvaniaTerminadoPaciente con cancerEstados Unidos
-
Peking Union Medical College HospitalTerminadoEncuesta | Estado nutricional | Paciente con cancerPorcelana
-
Ankara Medipol UniversityReclutamientoCuidados personales | Inmunoterapia | Manejo de síntomas | Paciente con cancerPavo
-
Northwestern UniversityGenzyme, a Sanofi CompanyRetiradoCANCER DE PROSTATAEstados Unidos
-
Fundacao ChampalimaudTerminado
-
University College London HospitalsTerminado
-
GenSpera, Inc.RetiradoCancer de prostata.Estados Unidos
-
University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
-
Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
Ensayos clínicos sobre Involved field irradiation
-
Novar CorporationTerminado
-
Turku University HospitalSatakunta Central HospitalTerminado
-
Encore Medical, L.P.ReclutamientoFracturas de tobillo bimaleolarEstados Unidos
-
Queen's University, BelfastUniversity of SussexDesconocido