Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma - PDAC-GS/GA-rP2, CSGO-HBP-015

Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group0 sites100 target enrollmentApril 1, 2016

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pancreatic ductal adenocarcinoma
Sponsor: Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group
Enrollment: 100
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

April 1, 2016

End Date

October 25, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group

•1\) Unresectable pancreatic cancer 2\) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. 3\) Watery diarrhea 4\) Severe infection 5\) Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 6\) Massive pleural or abdominal effusion. 7\) Metastasis to central nervous system. 8\) Active synchronous or metachronous malignancy other than carcinoma in situ. 9\) Regular use of frucitocin, fenitoin or warfarin 10\) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 11\) Severe mental illness 12\) Severe allergy for drugs 13\) Patients who are judged inappropriate for the entry into the study by the investigator.