jRCTs031180270已完成不适用
Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer (Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer(ASMET))
未提供0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •Histologically confirmed invasive ductal carcinoma of pancreas and after radical pancreatic resection
- •The primary tumor has been macroscopically complete resected and meet all of the following the histopathological staging in UICC seventh edition
- •StageIIor less
- •StageIII underwent celiac artery resection for complete tumor removal
- •Local residual tumor status is
- •Intraoperative peritoneal lavage cytology is negative
- •Neither distant metastasis nor malignant ascites
- •Oral nutrition is sufficiently maintained
- •No previous cancer treatment history other than pancreatic resection for pancreatic cancer
- •The patient is >= 20 years old at the time of obtaining informed consent
- •The patient has an Eastern Cooperative Oncology Group(ECOG)Performance Status (PS) of 0 or 1
- •The patient discontinued any chemotherapy and any radiotherapy>= 3years prior to randomization
- •The patient received radical pancreatic resection within 12 weeks prior to randomization
- •Impaired glucose tolerance was observed to meet one of the following diagnostic criteria for diabetes even once throughout the entire period prior to randomization
- •Fasting plasma glucose level>= 126mg/dl
- •Plasma glucose level at any time>=200mg/dl
- •Diabetes type in 75gOGTT
- •HbA1c(NGSP) >= 6.5%
- •HbA1c(JDS) >= 6.1%
- •The patient has adequate major organ function and meet all of the following requirements within 7 days prior to randomization:(HBs antigen test is only allowed within 28 days prior to randomization.)
- •White blood cell count(WBC) >=3,000/mm3 and<= 12,000/mm3
- •Absolute neutrophil count(ANC) >=1,500/mm3
- •Platelets>=100,000/mm3
- •Hemoglobin>=8.0g/dL
- •Total bilirubin<=2.0mg/dL
- •Aspartate transaminase(AST) and alanine transaminase(ALT) <=150IU/L
- •Serum creatinine<=1.5mg/dL
- •Ccr>=50mL/min
- •HBs antigen is negative
- •The patient has provided signed informed consent prior to randomization
排除标准
- •Any previous therapy with S-1 or any DPP-4 inhibitor or any GLP-1
- •Any anticancer therapy,(including hormone therapy, immunotherapy, and natural-origin and plant supplement etc.)within 1-year prior to randomization and any neoadjuvant therapy
- •A history of serious complications associated with resection
- •Reccurence in the examination prior to randomization
- •But it is not concluded that only incomplete decrease of tumor marker or only tiny ascites with CT means recurrence
- •Moderate or more pleural effusion or ascites with chest X-ray or abdominal CT
- •Apparent pulmonary fibrosis or interstitial pneumonia with chest X-ray or with clinical symptom
- •A history of gastrointestinal disorder concerning for dehydration status
- •Symptomatic congestive heart failure: New York Heart Association III-IV
- •Severe ketosis, diabetic coma or pre-coma, or type 1 diabetes
- •Malnutrition, starvation, general prostration condition, pituitary dysfunction or adrenal insufficiency.
- •A history of onset of myocardial infarction within 6 months
- •Active infection
- •Positive for HBs antigen
- •A history blood transfusion within 2 weeks prior to randomization
- •A history of lactic acidosis
- •Moderate or severe renal dysfunction or has received dialysis
- •Severe liver dysfunction
- •The patient tends to run into hypoxia status
- •The patient intakes excessive alcohol
- •Other severe complication
- •Any psychosis or psychiatric symptoms
- •Active multiple primary cancer(simultaneous one or heterochronous one accompanied by disease-free time within 3 years)
- •A female with pregnancy , breast-feeding,possibility of pregnancy,intention of pregnancy, or desire od delivery
- •A male with intention of having children.
- •The patient receives flucytosine, phenytoin, or warfarin potassium
- •The patient is determined to be unsuitable to safely carry out the study
结局指标
主要结局
-
2-years survival rate (overall survaival)
次要结局
未报告次要终点
研究者
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