Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- chemotherapy complete rate
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.
详细描述
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-70 years
- •Histologically proven adenocarcinoma of the stomach
- •Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery
- •Stage II, III (AJCC 7th edition)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •No prior chemotherapy or radiotherapy
- •Adequate bone marrow, renal, and liver function
排除标准
- •Any evidence of metastatic disease (including presence of tumor cells in the ascites).
- •Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- •Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- •Pregnant or lactating women.
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- •Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
- •Organ allografts requiring immunosuppressive therapy.
- •Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- •Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications.
- •Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.
研究组 & 干预措施
treatment
s1+oxaliplatin
干预措施: s1 (Drug)
treatment
s1+oxaliplatin
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
chemotherapy complete rate
时间窗: 6 months
percentage of patients who completed eight cycles of chemotherapy
次要结局
- overall survival(OS)(3 years)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(3 years)
- recurrence-free survival(RFS)(3 years)
研究者
Lin Yang
associated professor
Chinese Academy of Medical Sciences