- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01670409
Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer
A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Esophageal cancer is one of the most common malignant diseases in China, especially in Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per fraction generally. However, although with such comprehensive method, noncontrol of local disease or recurrence is still the main reason of failure.
Most patients with esophageal cancer suffer from malnutrition. A number of factors including hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local failures of disease after treatment; therefore a higher radiation biological equivalent dose (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial had shown that simply increasing total radiation dose could not gain better local control or overall survival rate, however, the ability of this trial to test the potential benefits of higher radiation dose could be compromized by the deficiencies within them, such as, observation bias,large radiated target volume and usage of conventional radiation technique. In other words, the probability that increasing radiation may help improving the control of disease should not be denied.
Modern radiation techniques, such as intensity modulation radiation therapy (IMRT), specially, are able to improve the coverage of target volumes and sparing of critical structures, while increase the total radiation dose. By using simultaneous modulated accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per fraction could be reduced significantly, while the doses to tumor could be increased to higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with conventional technique.
Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late toxicities would be tolerable and slighter than that of conventional technique.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdong
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Shantou, Guangdong, Porcelana, 515031
- Cancer Hospital, Shantou University Medical College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
- the primary disease located in cervical, upper or middle thoracic esophagus
- no distant metastases
- zubrod performance status: 0~2
- life expectancy > 6 months; -absence of another malignancy
- adequate liver, renal and bone marrow function
- women of childbearing potential and male participants must practice adequate contraception
- patient must provide study-specific informed consent prior to study entry
Exclusion Criteria:
- evidence of tracheoesophageal or Mediastinal-esophageal fistula
- prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
- prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
- pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
- women who are nursing
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: SMART combined with PF chemotherpay
SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)
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The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.
Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4.
Two cycles during radiation treatment on d1 and d28.
Two additional cycles after radiation treatment, 4 weeks per cycle.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Toxicities
Periodo de tiempo: The period during treatment and the 2 years after treatment
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The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs as assessed by CTCAE 4.0
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The period during treatment and the 2 years after treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Local control rate
Periodo de tiempo: 2 years after treatment
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The percentage of patients without locoregional tumor recurrence 2 years after treatment
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2 years after treatment
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overall survival rate
Periodo de tiempo: 2 years after treatment
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The percentage of patients that are alive 2 years after treatment
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2 years after treatment
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Complete blood count
Periodo de tiempo: before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)
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The complete blood count as assessed by a Coulter (LH 750 Haematology Analyzer)
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before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chuangzhen Chen, MD, Cancer Hospital, Shantou University Medical College
Publicaciones y enlaces útiles
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 (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 del Sistema Digestivo
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias de Cabeza y Cuello
- Enfermedades esofágicas
- Neoplasias De Células Escamosas
- Carcinoma De Células Escamosas
- Neoplasias Esofágicas
- Carcinoma de células escamosas de esófago
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Antimetabolitos, Antineoplásicos
- Antimetabolitos
- Agentes antineoplásicos
- Agentes inmunosupresores
- Factores inmunológicos
- Cisplatino
- Fluorouracilo
Otros números de identificación del estudio
- SUMC-ECA-001
- ChiCTR-ONC-12002356 (Identificador de registro: Chinese Clinical Trial Registry)
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. .
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