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eoadjuvant nab-paclitaxel plus gemcitabine therapy for resectable pancreatic cancer; A phase II multicenter trial

Not Applicable
Conditions
Resectable pancreatic cancer
Registration Number
JPRN-UMIN000031822
Lead Sponsor
Hokkaido Pancreatic Cancer Study Group (HOPS)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

1.GEM, nab-PTX or fluorinated pyrimidine anticancer drugs have been treated. 2.Severe diarrhea with uncontrolled bowel movement 3.Phenytoin, warfarin potassium, flucytosine are used. 4.History of sever allergic reaction with nab-paclitaxel, paclitaxel or albumin 5.Drug allergy to iodine contrast medium and impossible to perform contrast CT imaging. However, do not exclude the case of contrast-enhanced CT imaging with steroid prophylaxis. 6.Pulmonary fibrosis or interstitial pneumonia 7.Patients with medium or more pleural effusion or ascites 8.Active infection (Clinically stable HBV and chronic viral hepatitis by HCV are excluded). 9.Uncontrolled diabetes 10.Active double cancer (Synchronous double cancer and metachronous double cancer with disease-free period within 3 years). However, lesions such as carcinoma in situ that are cured by topical therapy are not included in active double cancers. 11.Active digestive ulcer 12.Serious complications (heart failure, renal failure, liver failure, intestinal palsy, etc). 13.Myocardial infarction within six months 14.Continuous systemic administration of steroids 15.Sever mental disorder 16.Women who are pregnant / lactating or pregnant or willing, or wish to baby. 17.A man who wishes to become a partner's pregnant. 18.Inappropriate physical condition as diagnosed by the attending physician

Study & Design

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