NCT02817425Unknown2 期
A Efficacy and Tolerability Study of Uracil/Ftorafur/Leucovorin Combined With Oxaliplatin (TEGAFOX) Sequential S-1 or SOX Sequential S-1 and S-1 Monotherapy in the Treatment of Adjuvant Chemotherapy for Gastric Cancer
LanZhou University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall Survial (OS)
研究概览
简要总结
This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.
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
- •75≧Age≧18
- •Histologically or cytologically confirmed gastrointestinal cancer
- •Stage Ⅱ or Ⅲ or Ⅳ
- •Accept the gastric cancer radical resection
- •Life expectancy of at least three months
- •Written informed consent to participate in the trial
排除标准
- •History of severe hypersensitivity reactions to the ingredients of S-1\TF\5-FU/calcium folinate or oxaliplatin
- •Inadequate hematopoietic function which is defined as below:
- •white blood cell (WBC) less than 5x10^9/L
- •absolute neutrophil count (ANC) less than 2x10^9/L
- •platelets less than 100*10^9/L
- •Inadequate hepatic or renal function which is defined as below:
- •serum bilirubin greater than 2 times the upper limit of normal range
- •alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
- •blood creatinine level greater than 2 times ULN
- •Presence of peripheral neuropathy
- •Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
- •Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
- •Psychiatric disorder or symptom that makes participation of the patient difficult;
- •Concomitant illness that might be aggregated by active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia with in six months
- •Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
研究组 & 干预措施
SOX Sequential S-1 Group
Active Comparator
Patients received chemotherapy with" oxaliplatin+ S-1 " for 6 months and sequential "S-1" for 6 months
干预措施: SOX Sequential S-1 (Drug)
SOX Group
Active Comparator
Patients received chemotherapy with" oxaliplatin+ S-1 " for 12 months
干预措施: SOX (Drug)
TEGAFOX Sequential S-1
Experimental
Patients received chemotherapy with" TEGAFOX (oxaliplatin+ Tegafur +Leucovorin Calcium) " for 6 months and sequential "S-1" for 6 months
干预措施: TEGAFOX Sequential S-1. (Drug)
结局指标
主要结局
Overall Survial (OS)
时间窗: Event driven, an expected average of 48 months
次要结局
- Disease Free Survial(Event driven, an expected average of 24 months)
- Safety (Adverse Events)(Adverse events will be assessed at baseline (after the patients provided signed Informed Consent Form) until at least 4 weeks after the last dose of study drug was administered, an expected average of 3week)
- Dose intensity(Event driven, an expected average of 48 months)
研究者
Xiao Chen, MD
Head of department
LanZhou University
研究点 (1)
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