The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Completion rate during the 12 weeks in the short hydration group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously
- •Patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks
- •Older than 20 years old
- •Eastern Cooperative Oncology Group Performance status of 0 or 1
- •Adequate main organ function
- •Fully oral intake ability to drink 500ml of solution before chemotherapy
- •Estimated life expectancy no less than 3 months
- •Written informed consent
排除标准
- •Patients who received cisplatin previously
- •Radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia
- •Patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months
- •Patients with serious infection
- •Pregnant or lactating female or patients who wish pregnant
- •Patients having severe allergy
- •Patients with other serious comorbid diseases
- •Patients with severe psychological disease
- •Patients with uncontrollable watery diarrhea
- •Patients with moderate or severe ascites /pleural effusion
- •Patients with severe psychological disease
- •Patients who are positive for a test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir
- •Patients who is judged as an inappropriate case by the investigator
研究组 & 干预措施
Oral rehydration group（Short Hydration）
Gemcitabine； gemzer Cisplatin；Cispulan Oral Rehydration Solution(ORS)；OS-1
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.
干预措施: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS) (Drug)
Standard group（Long Hydration）
Drug: Gemcitabine , Cisplatin
Other Names:
Gemcitabine； gemzer Cisplatin； Cispulan
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.
干预措施: Gemcitabine , Cisplatin (Drug)
结局指标
主要结局
Completion rate during the 12 weeks in the short hydration group
时间窗: 12 weeks
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.
次要结局
- Overall survival(6 months)
- Rate of renal toxicity(12 weeks)
- Adverse events(12 weeks)
- Marker of renal function(12 weeks)
- Response rate(12 weeks)
- Time to treatment failure(6 months)
- Progression free survival(6 months)