A phase II trial of Neoadjuvant and adjuvant chemotherapy with Gemcitabine and TS-1 combination for patients with locally advanced pancreatic cancer

Phase 2

• Conditions: pancreatic cancer

• Registration Number: JPRN-UMIN000005578
• Lead Sponsor: Chiba study group of adjuvant chemotherapy for pancreatic cancer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

1) History of sever allergic reaction with gemcitabine or s-1 2)Sever myelosuppression 3) Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 4)Serious renal dysfunction 5)Serious liver dysfunction 6)Patients under treatment with other furuorouracil related chemotherapy 7)Patients under treatment with flucytosine. 8)Pulmonary fibrosis or interstitial pneumonia 9)History of breast or lung radiation 10)Active infection 11)Patients with pleural effusion 12)Evidence of distant metastasis 13)Active double cancer 14)Uncontrolled heart diseases such as angina, myocardial infarction within three months, and cardiac dysfunction 15)Uncontrolled diabetes or hypertension 16)Sever mental disorder 17)Inadequate physical condition, as diagnosed by primary physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R0 resection rate

Secondary Outcome Measures

Name	Time	Method
resection rate (R0+1), overall survival, disease free survival, pathological chemotherapy effect, adverse events, recurrence type, tumor marker, relative dose intensity, tumor response rate, surgical morbidity