The Efficacy and Safety of S-1 Plus Oxaliplatin in First-line Treatment of Ederly Patients With Advanced or Recurrent Gastric Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
Elderly patients have poor tolerance and physical condition, we will prove 2-week schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.
详细描述
3-week plan of S-1 plus Oxaliplatin has been widely used,but it also has cumulative toxicity.Meanwhile elderly patients have poor tolerance and physical condition, we will prove 2-weeks schedule of oxaliplatin plus S-1 have a good efficacy and a better safety for elderly patients with advanced or recurrent gastric cancer.Untreated elderly patients with advanced or recurrent gastric cancer will receive Oxaliplatin 85 mg/m2 (D1, q2w) and S-1(40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w) as the first-line treatment. We will investigate the efficacy and safety of the combination treatment, and expect to provide a good effective treatment plan and a better safety for elderly patients with advanced or recurrent gastric cancer in China.The primary endpoint is progression-free survival(PFS), and the secondary endpoints are objective response rate(ORR), overall survival(OS) and the safety.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unresectable or recurrent gastric or gastroesophageal junction adenocarcinoma;
- •ability of oral administration;
- •CT or MRI can be used to assess measurable or non-measurable lesions according to the criteria of Response Evaluation Criteria In Solid Tumours (RECIST 1.1);
- •Untreated
- •more than 12 months after the last adjuvant/neoadjuvant chemotherapy;
- •ECOG=0-2;
- •Available organ function: ALT≤2.5xULN;AST≤2.5xULN;If patients have hepaticmetastasis,ALT≤2.5xULN,AST≤2.5xULN;ALP≤2xULN;TBIL≤1.0xULN;NEUT≥1.5×109/L;PLT≥100×109/L;Hb≥90g/L;Creatinine≤1.0xULN;Creatinine Clearance≥60ml/min
- •Informed consent;
- •Expected survival more than 3 months;More than 3 weeks after major surgery.
排除标准
- •Neoadjuvant and/or adjuvant have been treated with more than two plans;
- •In the past two years, the total dose of oxaliplatin≥800mg/m2;
- •Other cancers in the past 5 years,except for cervical carcinoma in situ or non-melanoma skin cancer;
- •Symptomatic brain metastases or soft meningeal metastasis;
- •Myocardial infarction (in the last 6 months), severe instability angina, congestive heart failure;
- •Serious complications (including intestinal paralysis, gastrointestinal obstruction, interstitial pneumonia, pulmonary fibrosis, uncontrolled diabetes, renal insufficiency and cirrhosis); Chronic nausea, vomiting or diarrhea (more than 4 times per day, or watery);Gastrointestinal bleeding requires regular blood transfusion;HIV or AIDS; Mental illness; Neuropathy grade≥2;Infectious diseases or inflammation, temperature≥38℃;
- •Known allergy to drugs in the study;
- •Pregnant or lactating women;
- •Both male and female subjects of potential fertility have to agree effective birth control during the entire study;
- •Experimental drugs used no more than 4 weeks;
- •Other conditions the researchers considered ineligible for the study.
研究组 & 干预措施
S-1 Plus Oxaliplatin
Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w)
干预措施: S-1,Oxaliplatin (Drug)
结局指标
主要结局
PFS
时间窗: 6 months
Progression-free survival
次要结局
- ORR(6 months)
- OS(1 year)
- The number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 year)
研究者
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences