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.
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. In many institutions in Japan, GC therapy is performed over 3 hours or more, longer than original method in the ABC-002 trial. Oral rehydration therapy is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. Oral rehydration therapy (ORT) is a therapy that performs prevention or treatment of dehydration by the ingestion of oral rehydration solution, which is adjusted the concentration of the electrolyte and glucose to absorb good efficiency from the gastrointestinal tract. Many reports suggest ORT may substitute for infusion therapy. Herein, the investigators planned the study to examine the safety of replacing the fluid infusion by oral rehydration expecting to shorten the time to drip.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Short hydration via oral rehydration solution (OS-1) Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively.
Standard hydration via intravenous infusion Cisplatin plus gemcitabine will be administered via usual infusion regimen by each hospital. In general, it is administered total 2 litters over 3 hours or more.
Osaka University, Graduate School of Medicine
Osaka, Japan
Completion rate during the 12 weeks in the short hydration group
Completion rate during the 12 weeks in the short hydration group is defined as percentage proportion of treatment complete cases for 12 weeks of the eligible cases. Treatment completion is defined as carrying out a short hydration regimen via ORT.
Time frame: 12 weeks
Rate of renal toxicity
Time frame: 12 weeks
Adverse events
Time frame: 12 weeks
Marker of renal function
Time frame: 12 weeks
Response rate
Time frame: 12 weeks
Time to treatment failure
Time frame: 6 months
Progression free survival
Time frame: 6 months
Overall survival
Time frame: 6 months
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