Overview

Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer

Status:
Completed
Trial end date:
2016-07-07
Target enrollment:
0
Participant gender:
All
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 gemcitabine and cisplatin.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kansai Hepatobiliary Oncology Group
Treatments:
Cisplatin
Gemcitabine
Pharmaceutical Solutions
Criteria
Inclusion Criteria: 1. 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

- 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

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