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A phase II trial of adjuvant chemotherapy with 5-FU liver perfusion chemotherapy via the portal vein followed by gemcitabine plus S-1 (F-GS therapy) for patients with resectable pancreatic cancer (CCOG-1001)

Phase 2
Conditions
resectable pancreatic cancer
Registration Number
JPRN-UMIN000003768
Lead Sponsor
Chubu Clinical Oncology Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion Criteria

1) serious intra- or postoperative complications 2) regular use of fenitoin, warfarin or frucitocin 3) systemic administration of other fluorouracil 4) intractable watery diarrhea 5) severe psychological disease 6) active infection 7) serious complications (bowel paralysis, bowel obstruction, uncontrollable diabetes mellitus, heart failure, renal failure, active peptic ulcer, deep venous thrombosis and so on) 8) serious myelosuppression 9) interstitial pneumonia or pulmonary fibrosis 10) radiotherapy to the chest 11) pleural effusion or ascites 12) active malignancy in other organ 13) allergic reaction for gemcitabine or S-1 14) chronic liver damage 15) impossible insertion of the catheter to the portal vein 16) pregnant or breast feeding 17) Patients judged inappropriate for the study by the physicians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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