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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Kansai Hepatobiliary Oncology Group

Current Primary Outcome: Completion rate during the 12 weeks in the short hydration group [ Time Frame: 12 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of renal toxicity [ Time Frame: 12 weeks ]
  • Adverse events [ Time Frame: 12 weeks ]
  • Marker of renal function [ Time Frame: 12 weeks ]
  • Response rate [ Time Frame: 12 weeks ]
  • Time to treatment failure [ Time Frame: 6 months ]
  • Progression free survival [ Time Frame: 6 months ]
  • Overall survival [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Kansai Hepatobiliary Oncology Group

Dates:
Date Received: August 4, 2013
Date Started: May 2013
Date Completion: March 2018
Last Updated: August 31, 2016
Last Verified: August 2016