PDAC-GS/GA-rP2
- Conditions
- Pancreatic ductal adenocarcinoma
- Registration Number
- JPRN-jRCTs051180122
- Lead Sponsor
- Kobayashi Syogo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2. Patients of age =>20
3. Performance Status:0-1(ECOG)
4. Resectable pancreatic cancer
5. Life expectancy more than 6 months.
6. Sufficient organ functions.
(1) neutrophils >=1,500/mm3
(2) platelets >=100,000/mm3
(3) hemoglobin >=9.0g/dl
(4) AST(GOT)/ALT(GPT) <=150IU
(5) total bilirubin <=2.0mg/dl
(or <=3.0mg/dl if biliary drainage were present)
(6) serum creatinine <=1.2mg/dl
(7) creatinine clearance>=60ml/min
7. No treatment before application for this tumor
8. Written informed consent.
1) Unresectable pancreatic cancer
2) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
3) Patients with Brinkman Index =>200
4)Watery diarrhea 5) Severe infection
6) Severe complication
(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
7) Massive pleural or abdominal effusion.
8) Metastasis to central nervous system.
9) Active synchronous or metachronous malignancy other than carcinoma in situ.
10) Regular use of frucitocin, fenitoin or warfarin
11) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
12) Severe mental illness 13) Severe allergy for drugs
14) Patients who are judged inappropriate
for the entry into the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method