Randomized Controlled Trials on Adjuvant Intraperitoneal Chemotherapy for Resectable Local Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Metastasis in Peritoneum and peritoneal cavity
研究概览
简要总结
Gastric cancer is the leading cause of death from a intestinal tract cancer in China.In most cases, the high death rate is due to tumor that has spread beyond the gastric cancer at the time of diagnosis. In China, the standard chemotherapy for the initial treatment of gastric cancer is a combination of a platinum analogue with 5-Fu.With modern surgical interventions and contemporary chemotherapy, most patients attain better clinical remission.The majority of them, however, will eventually have a relapse and die of the disease.
The peritoneal cavity is the principal site of disease in gastric cancer.Although the intensity of intravenous chemotherapy is limited mainly by myelotoxicity, several active drugs can be administered directly into the peritoneal cavity. The rationale for intraperitoneal therapy in gastric cancer is that the peritoneum, the predominant site of tumor, receives sustained exposure to high concentrations of antitumor agents while normal tissues, such as the bone marrow, are relatively spared.
The investigators conducted this trial to investigate the efficacy and safety of intraperitoneal chemotherapy in advanced gastric cancer.
详细描述
To investigate efficacy and safety of intraperitoneal chemotherapy as part of adjuvant treatment for advanced gastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •DISEASE CHARACTERISTICS
- •Histologically confirmed primary adenocarcinoma of the stomach
- •3-4weeks after radical operation for gastric cancer
- •Stage of the gastric cancer was T3-4NxM0
- •PATIENT CHARACTERISTICS:
- •Age: 18 - 70years old
- •Life expectancy:
- •Longer than 3 months
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 80*10^12/mm3
- •AST no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Prior chemotherapy and radiotherapy were not allowed
- •No other concurrent chemotherapy
- •Radiotherapy:
- •Locally radiotherapy for local disease of advanced gastric cancer during adjuvant treatment was allowed
- •See Disease Characteristics
- •Prior surgery for gastric cancer was necessary
排除标准
- •Haven't recovery from operation or complication of operation
- •With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
- •Pregnant or nursing
- •Other currently active malignancy except nonmelanoma skin cancer
- •Uncontrolled or severe bleeding,diarrhea,intestinal obstruction,adhesion of intestine
- •metastasis before enrollment
- •Received other chemotherapy or radiotherapy after operation
研究组 & 干预措施
IP Chemo arm
adjuvant system intravenous chemotherapy combined with adjuvant intraperitoneal chemotherapy
干预措施: cisplatin, Fluorouracil (Drug)
结局指标
主要结局
Metastasis in Peritoneum and peritoneal cavity
时间窗: 1 year
次要结局
- Liver metastasis(1 year)
- Refraction-free survival(1 year)
- Overall survival(1 year)