UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010695 |
|---|---|
| Receipt number | R000012500 |
| Scientific Title | The feasibility study of Oral rehydration therapy for Short hydration in chemotherapy with cisplatin plus gemcitabine for biliary tract cancer |
| Date of disclosure of the study information | 2013/05/13 |
| Last modified on | 2016/07/07 19:21:07 |
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Basic information
Public title
The feasibility study of Oral rehydration therapy for Short hydration in chemotherapy with cisplatin plus gemcitabine for biliary tract cancer
Acronym
Oral rehydration therapy for Short hydration in chemotherapy with CDDP plus GEM for biliary tract cancer: KHBO1302
Scientific Title
The feasibility study of Oral rehydration therapy for Short hydration in chemotherapy with cisplatin plus gemcitabine for biliary tract cancer
Scientific Title:Acronym
Oral rehydration therapy for Short hydration in chemotherapy with CDDP plus GEM for biliary tract cancer: KHBO1302
Region
| Japan |
Condition
Condition
biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Completion rate during the 12 weeks in the short hydration group
Key secondary outcomes
Rate of renal toxicity, adverse events, marker of renal function, response rate, time to treatment failure, progression free survival, overall survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food |
Interventions/Control_1
Short hydration via oral rehydration solution (OS-1)
Interventions/Control_2
Standard hydration via intravenous infusion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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. PS 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
Key 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
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
Yamadaoka 2-2, Suita city, Osaka, JAPAN
TEL
0668793258
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sakai |
Organization
Osaka University, Graduate School of Medicine
Division name
Department of Frontier Science for Cancer and Chemotherapy
Zip code
Address
Yamadaoka 2-2, Suita city, Osaka, JAPAN
TEL
0668792641
Homepage URL
dsakai@cfs.med.osaka-u.ac.jp
Sponsor or person
Institute
Kansai Hepatobiliary Oncology Group (KHBO)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01917617
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 12 | Day |
Last modified on
| 2016 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012500
