Status:
COMPLETED
Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer
Lead Sponsor:
Kansai Hepatobiliary Oncology Group
Conditions:
Biliary Tract Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and feasibility of oral rehydration therapy for short hydration in patients with biliary tract cancer who will undergo the chemotherapy including ...
Detailed Description
A large amount of fluid infusion is required to load for the prevention of renal dysfunction by Cisplatin in combination of GC therapy. There is a problem infusion time is take a long time for this. I...
Eligibility Criteria
Inclusion
- Patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously 2. Patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks 3. Older than 20 years old 4. Eastern Cooperative Oncology Group Performance status of 0 or 1 5. Adequate main organ function 6. Fully oral intake ability to drink 500ml of solution before chemotherapy 7. Estimated life expectancy no less than 3 months 8. Written informed consent
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Exclusion
- 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
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Key Trial Info
Start Date :
May 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01917617
Start Date
May 22 2013
End Date
July 7 2016
Last Update
February 21 2019
Active Locations (1)
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1
Osaka University, Graduate School of Medicine
Osaka, Japan, 565-0871