A Phase II Study of Adjuvant Chemotherapy of S-1 With Oxaliplatin in Gastric Cancer at Stage IIIB/ IV (AJCC 6th) After D2 Resection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- 3-year recurrence-free survival, RFS
研究概览
简要总结
After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who voluntarily provide written informed consent prior to entering into this study
- •Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- •Patients who underwent radical resection with wide lymph node dissection
- •TNM stage (6th AJCC) of IIIB or IV on post-operative staging
- •Patients who can be randomized within 6 weeks after surgery
排除标准
- •Aged < 20 years or ≥ 76 years
- •Eastern Cooperative Oncology Group (ECOG) performance status >2
- •Patients who underwent surgery for neoplasm in stomach in the past
- •History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
- •Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
- •Residual cancer on post-operative staging (R1 and R2 resection)
- •Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
- •Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
- •Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
- •Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
- •History of hypersensitivity to the investigational products (S1 and Oxaliplatin)
研究组 & 干预措施
S-1/Oxaliplatin
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
干预措施: S-1 (452500ACH) (Drug)
S-1/Oxaliplatin
S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
干预措施: OXALIPLATIN (205803BIJ) (Drug)
结局指标
主要结局
3-year recurrence-free survival, RFS
时间窗: 3-year
次要结局
- 5-year overall survival, OS(5-year)
研究者
Dong-Hoe Koo
Division of Hematology/Oncology, Department of Internal Medicine, Sungkyunkwan University School of Medicine
Kangbuk Samsung Hospital