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

NCT ID: NCT01917617

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-22
• Study Completion Date: 2016-07-07

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 gemcitabine and 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.

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS)

Intervention Type: DRUG

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 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.

Group Type: ACTIVE_COMPARATOR

Gemcitabine , Cisplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Gemcitabine； gemzer; Cisplatin；Cispulan; Oral Rehydration Solution(ORS)；OS-1; Gemcitabine； gemzer; Cisplatin； Cispulan

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kansai Hepatobiliary Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Nagano, MD, PhD

Role: STUDY_DIRECTOR

Osaka University Graduate School of Medicine

Locations

Osaka University, Graduate School of Medicine

Osaka, , Japan

Countries

Japan

Other Identifiers

UMIN000010695

Identifier Type: REGISTRY

Identifier Source: secondary_id

KHBO1302

Identifier Type: -

Identifier Source: org_study_id