Randomized open-label phase II study of adjuvant chemotherapy of S-1 plus metformin vs. S-1 alone in patients with resected pancreatic cancer

Phase 2

• Conditions: Pancreatic cancer

• Registration Number: JPRN-UMIN000020681
• Lead Sponsor: ational Hospital Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-22
• Last Update Posted: 17 October 2023
• Study Completion: 2024-01-26

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified