JPRN-jRCTs051180122
Recruiting
Phase 2
Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy in locally advanced pancreatic ductal adenocarcinoma - PDAC-GS/GA-rP2
Kobayashi Syogo0 sites100 target enrollmentMarch 13, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kobayashi Syogo
- Enrollment
- 100
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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