NCT02396498Unknown3 期
S-1 With Cisplatin Intravenous Chemotherapy Versus S-1 Plus Cisplatin Hyperthermic Intraperitoneal Chemotherapy in Stage Ⅲ Patients After D2 Gastrectomy：a Randomized Controlled Study
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- DFS: Disease-Free Survival
研究概览
简要总结
The study is designed to assess the safety and efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy in stage Ⅲ patients after D2 gastrectomy
详细描述
The study is a randomized clinical trial，and subjects wuill be assigned two arms: SP Intravenous Chemotherapy or SP by HIPEC .After 8 cycles treatment,we assess the safety and efficacy.
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
- •18 ≤ age ≤ 70 years old
- •Histologically diagnosed as stageⅢ gastric adenocarcinoma，and perform D2 radical gastrectomy，as well as have not received any Anti-tumor therapy：chemotherapy,biological treatment or molecular targeted therapy , etc.
- •The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- •Having given written informed consent prior to any procedure related to the study
- •Expected survival time ≥3 months
排除标准
- •History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin
- •Hemoglobin<90g/L
- •Inadequate hematopoietic function which is defined as below:
- •white blood cell (WBC) less than 3,500/mm^3
- •absolute neutrophil count (ANC) less than 1,500/mm^3
- •platelets less than 80,000/mm^3
- •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 1.5 times ULN,Creatinine clearance<60ml/min
- •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
- •Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
- •Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
- •Known DPD deficiency
- •Participate in other clinical trial before the start of this trial
- •Patient compliance is bad or researchers believe that patients are not suitable for this treatment
- •Known to have active hepatitis patients
研究组 & 干预措施
D2 radical gastrectomy+HIPEC
Experimental
8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after D2 radical gastrectomy. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance.
干预措施: HIPEC (Drug)
结局指标
主要结局
DFS: Disease-Free Survival
时间窗: 2 years
from the date of random to the date of recurrence or death for disease progression.
次要结局
- OS: Overall Survival(5 years)
- The quality of life(6 months)
- Safety as measured by Adverse Events and Serious Adverse events In the process of the total treatment according CTCAE4.0(6 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal MetastasisStage IV Gastric CancerNCT02291211Tang-Du Hospital60
已完成
1 期
Phase I study of S-1 plus cisplatin and intraperitoneal administration of paclitaxel for gastric cacner with peritoneal metastasisgastric cancer with peritoneal metastasisJPRN-UMIN000013528agoya University9
已完成
2 期
Phase 2 Study of S-1 in Combination With Cisplatin as 1st Line Therapy in Advanced Non-Small Cell Lung CancerAdvanced Non-Small Cell Lung CancerNCT00651833Taiho Oncology, Inc.60
已完成
2 期
S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical StudyEsophageal Squamous Cell CarcinomaNCT01854749Fudan University57
终止
3 期
Diffuse Gastric and Esophagogastric Junction Cancer S-1 TrialMetastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal JunctionNCT01285557Taiho Oncology, Inc.361