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Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

Phase 2
Conditions
pancreatic neoplasm
Registration Number
JPRN-C000000308
Lead Sponsor
Japan Clinical Oncology Group(JCOG)
Brief Summary

See the datails via "URL releasing results" above. Also the details can be seen in the JCOG website: http://www.jcog.jp/en/trials/index.html

Detailed Description

Not available

Recruitment & Eligibility

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

Not provided

Exclusion Criteria

Patients are excluded if they meet the following criteria: They have obvious ascetic or pleural effusion, lung fibrosis or pneumonitis, uncontrolled diabetes mellitus in spite of using more than 40 unit insulin, Classification of New York Heart Association (NYHA) of III or IV, myocardial infarction within 6 months before this trial, synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, or severe mental disease.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1-year overall survival
Secondary Outcome Measures
NameTimeMethod
clinical benefit response (CBR), CA19-9 response, adverse events
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