Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer (CAPITAL)
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.
Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Guangdong
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Chaozhou, Guangdong, Porcelana
- the central hospital of Chaozhou
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Foshan, Guangdong, Porcelana
- The 1st People's Hospital of Foshan
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Guangzhou, Guangdong, Porcelana
- Cancer center of Sun Yat-sen University
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Guangzhou, Guangdong, Porcelana
- cancer center of Guangzhou medical college
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Guangzhou, Guangdong, Porcelana
- Guangdong Traditional Medical Hospital
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Guangzhou, Guangdong, Porcelana
- the 1st affliated hospital of Guangdong pharmacuetic college
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Guangzhou, Guangdong, Porcelana
- the 1St Affliated Hospital of Guangzhou Medical College
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Guangzhou, Guangdong, Porcelana
- the 6th affliated hospital of Sun-yat-sen University
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Shantou, Guangdong, Porcelana
- the 1st hospital of Shantou University
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Shantou, Guangdong, Porcelana
- the cental hospital of Shantou
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Shaoguan, Guangdong, Porcelana
- YUE-BEI people's hospital
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Shenzhen, Guangdong, Porcelana
- The 2nd People's Hospital of Shenzhen
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Zhuhai, Guangdong, Porcelana
- the 5th hospital of Sun-yat-sen University
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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:
- informed consensus of patients
- be able to receive oral administration
- from 18 to 70 years old
- be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
- without other chemotherapy and/or radiation against to the disease
- normal function of other organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status:0~2
Exclusion Criteria:
- history of other malignancy
- allergic reaction to S-1 or oxaliplatin
- be enrolling in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
- other situation to be judged not adaptive to the study by investigators
Plan de estudios
¿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 |
|---|---|
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Experimental: S-1 plus Oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
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6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
Otros nombres:
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Comparador activo: S-1 single
S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
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16 courses S-1 single after d D2 resection
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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sobrevivencia promedio
Periodo de tiempo: 5 años
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5 años
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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supervivencia libre de enfermedad
Periodo de tiempo: 3 años
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3 años
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Número de participantes con eventos adversos
Periodo de tiempo: 5 años
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5 años
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Zhiwei Zhou, PHD, SunYat-sen University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SYSUCCGPS
- ZHOUZHIWEI (Identificador de registro: ZZHIWEI)
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