Pancreatic cancer
Conditions
Interventions
A:S-1+Metformin S-1 day1-14 of each 21-day cycle, until progression disease or completion of the planned 6 months Treatment for diabetes: Metformin 500mg/day day1-21, subsequently 750mg/day for 2 y
Sponsors
National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed invasive ductal carcinoma of pancreas and after radical pancreatic resection 2)The primary tumor has been macrospically 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
Exclusion criteria
Exclusion criteria: 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 neoajduvant 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 patienttends 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year survival rate (overall survaival) | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence free survival time Adverse event rate | — |
Countries
Japan
Contacts
Public ContactMasayuki Furukawa
National Kyushu Cancer Center Department of Hepato-Biliary-Pancreatology
Outcome results
None listed