Phase II study of S-1 plus Leucovorin for metastatic pancreatic adenocarcinoma (JASPAC 03)

Phase 2

• Conditions: metastatic pancreatic adenocarcinoma

• Registration Number: JPRN-UMIN000004958
• Lead Sponsor: Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

1) Required to continue to take flucytosine, phenytoin, and warfarin 2) Active infections 3) High fever(over 38 degrees) 4) Severe complications (heart failure, myocardial infarction, renal failure, liver cirrhosis, ileus, interstitial lung disease, uncontrolled diabetes, cerebrovascular disorder, severe mental disorder, and so on) 5)Uncontrollable watery diarrhea or severe bowel disorder 6) Simultaneous or metachronous (within 5 years) double cancers, with the exception of intramucosal tumor curable with local therapy 7) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 8) Patients requiring systemic steroids medication 9) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy 10) Inadequate physical condition, as diagnosed by primary physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate

Secondary Outcome Measures

Name	Time	Method
progression-free survival overall survival adverse events serious adverse events