Neoadjuvant S1, Oxaliplatin, and Docetaxel (SLOT) Versus S1, Oxaliplatin(SOX) in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- 5 year overall survival
研究概览
简要总结
gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.
详细描述
Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven gastric or GE junction adenocarcinoma;
- •Age: 18 to 70;
- •ECOG 0-2;
- •Adenocarcinoma of the stomach or GE junction according to staging classification TNM Scannographic: T3-4 N0/N + M0 ;
- •Completion of baseline quality of life questionnaire
- •Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);
- •Adequate renal functions(serum creatinine ≤ 1.5mg/dl)
- •liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)
- •Written informed consent
排除标准
- •Previous chemotherapy;
- •Active infection requiring antibiotics
- •Pregnant, lactating women
- •Psychiatric illness, epileptic disorders
- •Concurrent systemic illness not appropriate for chemotherapy
- •History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma
研究组 & 干预措施
SLOT group
4 cycles preoperative chemotherapy with Docetaxel+oxaliplatin+s1 . Gastric resection. 6 cycles adjuvant chemotherapy with sequential oxaliplatin+s1 or oxaliplatin+s1,then s1 for 6 months。
干预措施: Docetaxel;oxaliplatin;s1 (Drug)
SOX group
3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1
干预措施: oxaliplatin;s1 (Drug)
结局指标
主要结局
5 year overall survival
时间窗: 6 years
次要结局
- 3 year relapse free survival(5 years)
- Surgical complete resection rate (R0)(2.5 year)
- Pathological response rate(2.5 year)
研究者
Jing Huang
MD PhD
Chinese Academy of Medical Sciences