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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 22, 2013

Primary Completion Date

January 7, 2016

Study Completion Date

July 7, 2016

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."

Trial Locations (1)

565-0871

Osaka University, Graduate School of Medicine, Osaka

All Listed Sponsors
lead

Kansai Hepatobiliary Oncology Group

NETWORK

NCT01917617 - Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer | Biotech Hunter | Biotech Hunter