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

The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer

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.

Study Overview

• Status: Completed
• Conditions: Biliary Tract Cancer
• Intervention / Treatment: Drug: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS); Drug: Gemcitabine , Cisplatin

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. 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
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 565-0871
    • Osaka University, Graduate School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS); 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.; Other Names: Gemcitabine； gemzer; Cisplatin；Cispulan; Oral Rehydration Solution(ORS)；OS-1
Active Comparator: 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.	Drug: Gemcitabine , Cisplatin; 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.; Other Names: Gemcitabine； gemzer; Cisplatin； Cispulan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	12 weeks
Overall survival	6 months
Rate of renal toxicity	12 weeks
Marker of renal function	12 weeks
Response rate	12 weeks
Time to treatment failure	6 months
Progression free survival	6 months

Collaborators and Investigators

• Sponsor: Kansai Hepatobiliary Oncology Group

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2013
• Primary Completion (Actual): January 7, 2016
• Study Completion (Actual): July 7, 2016

Study Registration Dates

• First Submitted: August 4, 2013
• First Submitted That Met QC Criteria: August 4, 2013
• First Posted (Estimate): August 6, 2013

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Cisplatin; Pharmaceutical Solutions
• Other Study ID Numbers: KHBO1302; UMIN000010695 (Registry Identifier: UMIN)