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A Phase II trial of combination therapy of gemcitabine and hyperthermia in unresectable pancreatic cancer.

Phase 2
Conditions
unresectable pancreatic cancer
Registration Number
JPRN-UMIN000001221
Lead Sponsor
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
18
Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria in this study are as follows: 1. Interstitial pneumonitis, pulmonary fibrosis with radiological findings 2. Recurrence after resection for CBD cancer or presence of hepatocellular carcinoma, duodenal cancer, peritonitis carcinomatosa. 3. Presence of ileus 4. Presence of active biliary infection 5. Presence of uncontrolled diabetes, severe liver dysfunction, unstable angina, myocardial infarction within three months. 6. Presence of active severe infection 7. Pregnant, lactating women or women with suspected pregnancy. 8. Medical history of severe hypersensitivity. 9. Severe complications 10. Inappropriate patients for this study judged by the physicians.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1-year survival rate
Secondary Outcome Measures
NameTimeMethod
safety, performance status, response rate
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