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

NCT01917617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-21

No results posted yet for this study

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.

Conditions

  • Biliary Tract Cancer

Interventions

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.

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.

Sponsors & Collaborators

  • Kansai Hepatobiliary Oncology Group

    lead NETWORK

Principal Investigators

  • Hiroaki Nagano, MD, PhD · Osaka University Graduate School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-22
Primary Completion
2016-01-07
Completion
2016-07-07

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917617 on ClinicalTrials.gov