JPRN-UMIN000010695
Completed
Phase 2
The feasibility study of Oral rehydration therapy for Short hydration in chemotherapy with cisplatin plus gemcitabine for biliary tract cancer - Oral rehydration therapy for Short hydration in chemotherapy with CDDP plus GEM for biliary tract cancer: KHBO1302
Kansai Hepatobiliary Oncology Group (KHBO)0 sites50 target enrollmentMay 13, 2013
Conditionsbiliary tract cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- biliary tract cancer
- Sponsor
- Kansai Hepatobiliary Oncology Group (KHBO)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\. Patients who received cisplatin previously 2\. Radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia 3\. Patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months 4\. Patients with serious infection 5\. Pregnant or lactating female or patients who wish pregnant 6\. Patients having severe allergy 7\. Patients with other serious comorbid diseases 8\. Patients with severe psychological disease 9\. Patients with uncontrollable watery diarrhea 10\. Patients with moderate or severe ascites /pleural effusion 11\. Patients with severe psychological disease 12\. Patients who are positive for a test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir 13\. Patients who is judged as an inappropriate case by the investigator
Outcomes
Primary Outcomes
Not specified
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