gastroenteropancreatic neuroendocrine tumor (GEP-NET)(G1,G2,G3)
Conditions
Interventions
streptozocin+S-1
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient who was diagnosed gastroenteropancreatic neuroendocrine tumor (NET G1,G2,G3 from WHO 2010 classification) 2)1) and surgically non-resectable 3)Patient who underwent at least one or more regimen of systemic chemotherapy except streptozocin, fluorouracil related agents,and transcatheter arterial chemoembolization for liver metastasis. 4)ECOG Performance Status:0 or 1 5)Patient's laboratory results satisfy following criteria within 14 days before entry hemoglobin level:more than 9.0g/dL White blood cell:equal to or less than 12000/mm3 Neutrophil:more than 2000/mm3 Platelet:more than 100000/mm3 AST/ALT:equal to or less than 100 IU/L (equal to or less than 150 IU/L when underwent biliary drainage or choledochojejunostomy) Total bilirubin:equal to or less than 1.5 mg/dL(equal to or less than 2.0 mg/dL when underwent biliary drainage or choledochojejunostomy) Creatinine:equal to or less than 1.2 mg/dL Creatinine clearance:more than 60 mL/min(measured value or Cockcroft-Gault formula) 6)Patient is able to oral intake
Exclusion criteria
Exclusion criteria: 1)Patient who has double or more active cancer 2)Patient who is at risk of becoming pregnant, or in pregnancy. Male patient who is desiring future fertility for partner. 3)Psychiatric patient 4)Patient treated with systemic administration of steroid 5)Patient with pulmonary fibrosis or interstitial pneumonia 6)Patient who has watery diarrhea 7)Patient with an infection (except viral hepatitis) 8)Patient who has a severe complication (cardiac failure, renal failure, hepatic failure, peptic ulcer hemorrhage, paralytic ileus, severe diabetes mellitus) 9)Patient who has a blood transfusion before entry within 14 days 10)Patient who has mild pleural effusion or ascites or cariac effusion on X-ray or ultrasonography 11)Patient who has severe cardiac disease 12)Patient who takes flucytosine, phenytoin or warfarin potassium 13)Patient who has brain metastasis 14)Patient who was judged inadequate to join the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Dose Limited Toxicity (DLT) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) Progression-free Survival(PFS) Response Rate(RR) Adverse event rate | — |
Countries
Japan
Contacts
Public ContactYasunari Sakamoto
International University of Health and Welfare Atami Hospital Department of Gastroenterology and Hepatology
Outcome results
None listed