Phase Ⅱ Study of S-1 Combined With Oxaliplatin (SOX)Verse S-1 Combined With Cisplatin(SP) in Adjuvant Chemotherapy After D2 Surgery
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- replase free survival
研究概览
简要总结
To investigate the efficiency and safety of SOX or SP adjuvant chemotherapy to phase II and III gastric cancer patients after D2 surgery. If SOX is equal to SP in efficiency and less toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed Phase III adenocarcinoma of gastric and esophageal-gastric junction ( AJCC 7th)
- •without previous treatment, including radiotherapy, chemotherapy and immunotherapy
- •Hb≥90g/L,WBC 4×109/L-10×109/L,ANC≥2×109/L,Platelet≥100×109/L
- •creatinine≤1 UNL
- •total bilirubin≤1.5 UNL,AST(SGOT),ALT(SGPT) and ALP≤2.5 UNL
- •ECOG score 0 - 2
- •take chemotherapy for 8 weeks after surgery
- •older than 18 years
- •can be followed up, good compliance
- •can take medicine orally
- •having signed informed consent
排除标准
- •combined disease lead to Life Expectancy less than 3 years
- •any evidence to show metastasis,including cancer cells in peritoneal fluid
- •inability to take oral medication for difficult to swallow, intestinal obstruction，active intestinal blooding or perforation
- •previous treatment,including cytotoxic chemotherapy, radio chemotherapy or immunotherapy ( except corticosteroid hormone）
- •operation within 4 weeks, or not recovered from last major operation
- •allergy with fluorouracil
- •allergy with Platinum or any composition in research drugs
- •uncontrollable seizure disorder，central nervous system disease or mental disorders, and has clinical significance by judgement of researchers, or can influnce understanding of informed consent or compliance to take orally drugs
- •in the past 12 months, has clinical significant heart disease(active),such as symptomatic coronary heart disease, > =Stage II congestive cardiac failure;congestive heart failure as NYHA standard, or serious arrhythmias need take medicine( as Appendix 10th),or myocardical infarction.
- •pregnancy， lactation， women in child-bearing period and her spouses reject to take effictive method to conraception
- •other previous malignancy within 5 years, except healed skin basal cell carcinoma and carcinoma in cervix
- •peripheral neuropathy> grade 1 of CTCAEv3, except the neural abnormality patients who only lose deep tendon reflex（DTRs）.
- •serious complicated infection or other complicated diseases and hard to controll.
- •As one of belowing:
- •ANC < 2×109/L
- •Platelet<100×109/L
- •total bilirubin>1.5 UNL
- •ALAT、ASAT > 2.5 x ULN
- •ALP> 2.5 x ULN
- •Any investigational agent within the past 28 days. That is the patient had jioned another trial.
研究组 & 干预措施
S-1+oxaliplatin
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
干预措施: S-1 (Drug)
S-1+oxaliplatin
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d oxaliplatin: 65mg/m2, D1,D8, 3weeks/cycle after 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
干预措施: oxaliplatin (Drug)
S-1+cisplatin
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
干预措施: S-1 (Drug)
S-1+cisplatin
S-1: 80mg/m2, 3weeks/cycle(take for 14d, rest for 7d) cisplatin: 75mg/m2, D1, every 3 weeks After 6 cycles, then mono S-1 for 2-4 cycles, total 8-10 cycles.
干预措施: cisplatin (Drug)
结局指标
主要结局
replase free survival
时间窗: 3 months
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(3 months)
- overall survival(6 months)
研究者
Shen Lin
Director of GI oncology
Peking University