NCT01917617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2016

Completed
Last Updated

February 21, 2019

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

August 4, 2013

Last Update Submit

February 19, 2019

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Oral rehydration group（Short Hydration）

EXPERIMENTAL

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)

Standard group（Long Hydration）

ACTIVE COMPARATOR

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

Interventions

Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS)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.

Also known as: Gemcitabine； gemzer, Cisplatin；Cispulan, Oral Rehydration Solution(ORS)；OS-1
Oral rehydration group（Short Hydration）
Gemcitabine , CisplatinDRUG

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.

Also known as: Gemcitabine； gemzer, Cisplatin； Cispulan
Standard group（Long Hydration）

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osaka University, Graduate School of Medicine

Osaka, 565-0871, Japan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

GemcitabineCisplatinWorld Health Organization oral rehydration solution

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Hiroaki Nagano, MD, PhD

    Osaka University Graduate School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2013

First Posted

August 6, 2013

Study Start

May 22, 2013

Primary Completion

January 7, 2016

Study Completion

July 7, 2016

Last Updated

February 21, 2019

Record last verified: 2017-05

Locations

JP(1)