UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

heguchi@gesurg.med.osaka-u.ac.jp

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

Email

dsakai@cfs.med.osaka-u.ac.jp

Institute

Kansai Hepatobiliary Oncology Group (KHBO)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

Date of disclosure of the study information

2013

Year

05

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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