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

Phase 2

Completed

• Conditions: Pancreatic ductal adenocarcinoma

• Registration Number: JPRN-UMIN000021484
• Lead Sponsor: Clinical study group of Osaka university, Hepato-Biliary- Pancreatic group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-01
• Last Update Posted: 17 October 2023
• Study Completion: 2026-10-25

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival time

Secondary Outcome Measures

Name	Time	Method
Rate of curative resection, dose intensity, radiological/histological responses, recurrence type (if develop), overall survival and adverse events