Phase III, Randomized, Multicenter, Controlled Evaluation of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 772
- 试验地点
- 1
- 主要终点
- disease free survival
研究概览
简要总结
This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.
The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric adenocarcinoma
- •Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
- •All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can be enrolled
- •planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- •KPS > 60; ECOG performance status 0-2
- •Life expectancy > 6 months
- •Age: 20 to 75 years
- •No other severe disease and life expectancy less than five years
- •7 days before enrolled, baseline data should be finished including:
- •Granulocyte count ≥ 1.5×109/L;
- •platelet count ≥ 100×109/L;
- •Hemoglobin ≥ 90g/L;
- •hepatic < 1.5×ULN;
- •total bilirubin ≤ 1.0×ULN;
- •creatinine < 1.5×ULN;
- •PT-INR/PTT < 1.7× ULN
- •Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
- •Written informed consent and able to comply with the protocol
排除标准
- •Patient cannot undergo surgery or chemotherapy because of other severe disease
- •Be allergic to chemotherapy drugs
- •Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
- •Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
- •Within the last 5 years in patients with a history of other malignant diseases
- •Pregnant or breast-feeding women
- •Severe heart disease like symptoms of coronary heart disease, New York Heart Association (NYHA) grade II or worse congestive heart failure or cardiac arrhythmia having medications or myocardial infarction within the last 12 months
- •Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
- •Patients with a history of peripheral nerve disease
- •Patients who get organ transplant
- •lack of dihydropyrimidine dehydrogenase (DPD)
- •Infection or other disease failure to control
研究组 & 干预措施
Arm A:Neoadjuvant sox
Patients in arm a will receive (N=2-4) cycles of neoadjuvant SOX first, and then standard gastrectomy with D2 lymphadenectomy, and (8-N) cycles of adjuvant SOX adjuvant chemotherapy.
干预措施: Oxaliplatin+S-1 (Drug)
Arm B:Adjuvant SOX
Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.
干预措施: Adjuvant Oxaliplatin/S-1（SOX） (Drug)
结局指标
主要结局
disease free survival
时间窗: three years
SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death.
次要结局
- response rate(3 months)
- overall survival(five years)
- safety(six months)
研究者
Lin Chen
Chief of GI Surgeon
Chinese PLA General Hospital