Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01917617
Recruitment Status : Completed
First Posted : August 6, 2013
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Kansai Hepatobiliary Oncology Group

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.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS) Drug: Gemcitabine , Cisplatin Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility Study of Oral Rehydration Therapy for Short Hydration in Chemotherapy With Cisplatin Plus Gemcitabine for Biliary Tract Cancer
Actual Study Start Date : May 22, 2013
Actual Primary Completion Date : January 7, 2016
Actual Study Completion Date : July 7, 2016


Arm Intervention/treatment
Experimental: 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.

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.

Other Names:
  • Gemcitabine; gemzer
  • Cisplatin;Cispulan
  • Oral Rehydration Solution(ORS);OS-1

Active Comparator: 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.

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.

Other Names:
  • Gemcitabine; gemzer
  • Cisplatin; Cispulan




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of renal toxicity [ Time Frame: 12 weeks ]
  2. Adverse events [ Time Frame: 12 weeks ]
  3. Marker of renal function [ Time Frame: 12 weeks ]
  4. Response rate [ Time Frame: 12 weeks ]
  5. Time to treatment failure [ Time Frame: 6 months ]
  6. Progression free survival [ Time Frame: 6 months ]
  7. Overall survival [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: 1. Patients with histological or cytological diagnosis of biliary tract cancer who haven't received cisplatin previously 2. Patients who is planned to receive chemotherapy including gemcitabine and cisplatin for biliary cancer for more than 12 weeks 3. Older than 20 years old 4. Eastern Cooperative Oncology Group Performance status of 0 or 1 5. Adequate main organ function 6. Fully oral intake ability to drink 500ml of solution before chemotherapy 7. Estimated life expectancy no less than 3 months 8. Written informed consent

- Exclusion Criteria: 1. Patients who received cisplatin previously 2. Radiological and clinical evidence of pulmonary fibrosis or interstitial pneumonia 3. Patients with uncontrolled diabetes mellitus or severe liver dysfunction or unstable angina or myocardial infarction within 3 months 4. Patients with serious infection 5. Pregnant or lactating female or patients who wish pregnant 6. Patients having severe allergy 7. Patients with other serious comorbid diseases 8. Patients with severe psychological disease 9. Patients with uncontrollable watery diarrhea 10. Patients with moderate or severe ascites /pleural effusion 11. Patients with severe psychological disease 12. Patients who are positive for a test of hepatitis B virus surface antigen (HBs antigen) without controlled with entecavir 13. Patients who is judged as an inappropriate case by the investigator

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917617


Locations
Layout table for location information
Japan
Osaka University, Graduate School of Medicine
Osaka, Japan, 565-0871
Sponsors and Collaborators
Kansai Hepatobiliary Oncology Group
Investigators
Layout table for investigator information
Study Director: Hiroaki Nagano, MD, PhD Osaka University Graduate School of Medicine

Layout table for additonal information
Responsible Party: Kansai Hepatobiliary Oncology Group
ClinicalTrials.gov Identifier: NCT01917617     History of Changes
Other Study ID Numbers: KHBO1302
UMIN000010695 ( Registry Identifier: UMIN )
First Posted: August 6, 2013    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: May 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Pharmaceutical Solutions
Cisplatin
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs