S-1 Plus Docetaxel(DS) Versus S-1 Plus Oxaliplatin(SOX) as Postoperative Therapy for Stage II / III Gastric Cancer, a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.
Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.
This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.
详细描述
In this study, patients with gastric or EGJ adenocarcinoma who received D2 dissection and staged II or III, aged from 18 to 75 years and with ECOG PS ≤2 and adequate organ function, are stratified randomized according to pstage and location of primary lesion.
Group DS:
S-1 is orally administer by BSA (<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses a day after breakfast and dinner for 14 days every three weeks to a total of 16 cycles postoperatively.
Docetaxel 40mg/m2/3w from the second to the seventh cycles.
Group SOX:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consensus of patients
- •be able to receive oral administration
- •from 18 to 75 years old
- •be proven to be primary adenocarcinoma of stomach 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
排除标准
- •history of other malignancy
- •allergic reaction to S-1 or oxaliplatin of docetaxel
- •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
研究组 & 干预措施
DS
D2 resection -- S1 * 1 cycle + DS * 6 cycles + S1 * 9 cycles
干预措施: Docetaxel (Drug)
SOX
D2 resection -- SOX * 8 cycles + S1 * 8 cycles
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
disease-free survival
时间窗: 3 year
The interval from randomization to local recurrence, distant metastasis, death or the last follow-up
次要结局
- overall survival(5 year)
- Treatment related Adverse Events(1 year)
研究者
Jian Xiao
Associate Professor
Sixth Affiliated Hospital, Sun Yat-sen University