ASMET
- Conditions
- pancreatic cancer
- Registration Number
- JPRN-jRCTs031180270
- Lead Sponsor
- Hisano Terumasa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
1)Histologically confirmed invasive ductal carcinoma of pancreas and after radical pancreatic resection
2)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
R0 or R1
Intraoperative peritoneal lavage cytology is negative
3)Neither distant metastasis nor malignant ascites
4)Oral nutrition is sufficiently maintained
5)No previous cancer treatment history other than pancreatic resection for pancreatic cancer
6)The patient is >= 20 years old at the time of obtaining informed consent
7)The patient has an Eastern Cooperative Oncology Group(ECOG)Performance Status (PS) of 0 or 1
8)The patient discontinued any chemotherapy and any radiotherapy>= 3years prior to randomization
9)The patient received radical pancreatic resection within 12 weeks prior to randomization
10)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%
11)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
12)The patient has provided signed informed consent prior to randomization
1)Any previous therapy with S-1 or any DPP-4 inhibitor or any GLP-1
2)Any anticancer therapy,(including hormone therapy, immunotherapy, and natural-origin and plant supplement etc.)within 1-year prior to randomization and any neoadjuvant therapy
3)A history of serious complications associated with resection
4)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
5)Moderate or more pleural effusion or ascites with chest X-ray or abdominal CT
6)Apparent pulmonary fibrosis or interstitial pneumonia with chest X-ray or with clinical symptom
7)A history of gastrointestinal disorder concerning for dehydration status
8)Symptomatic congestive heart failure: New York Heart Association III-IV
9)Severe ketosis, diabetic coma or pre-coma, or type 1 diabetes
10)Malnutrition, starvation, general prostration condition, pituitary dysfunction or adrenal insufficiency.
11)A history of onset of myocardial infarction within 6 months
12)Active infection
13)Positive for HBs antigen
14)A history blood transfusion within 2 weeks prior to randomization
15)A history of lactic acidosis
16)Moderate or severe renal dysfunction or has received dialysis
17)Severe liver dysfunction
18)The patient tends to run into hypoxia status
19)The patient intakes excessive alcohol
20)Other severe complication
21)Any psychosis or psychiatric symptoms
22)Active multiple primary cancer(simultaneous one or heterochronous one accompanied by disease-free time within 3 years)
23)A female with pregnancy , breast-feeding,possibility of pregnancy,intention of pregnancy, or desire od delivery
24)A male with intention of having children.
25)The patient receives flucytosine, phenytoin, or warfarin potassium
26)The patient is determined to be unsuitable to safely carry out the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-years survival rate (overall survaival)
- Secondary Outcome Measures
Name Time Method Recurrence free survival time <br>Adverse event rate