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A multicenter phase II trial of everolimus for unresectable pancreatic neuroendocrine carcinoma refractory or intolerant to platinum-based regime

Phase 2
Conditions
nresectable pancreatic neuroendocrine carcinoma
Registration Number
JPRN-UMIN000012752
Lead Sponsor
ational Cancer Center Hospital East
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
25
Inclusion Criteria

Not provided

Exclusion Criteria

1) NET G1 or G2 by WHO 2010 criteria 2) Interstitial pneumonia or plumonary fibrosis 3) Metastasis to the central nervous system 4) Concomitant malignancy within 3 years 5) Active infection (exept for hepatitis B or C viral infection) 6) Active gastrointestinal ulcer 7) Severe or uncontrollable complications, such as cardiovascular impairment, infection, diabetes mellitus, and pulmonary disease 8) Severe mental disorder 9) Continuous administration of steroid or immunosuppressant 10) Prior treatment of mTOR inhibitor 11) Pregnant or lactating women and women of childbearing age who were not using effective contraception 12) Patients who was judged to be inappropriate for this study by each investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression free survival
Secondary Outcome Measures
NameTimeMethod
Overall survival, time to treatment failure, response rate, disease control rate, adverse events
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