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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001267
Receipt No. R000001381
Scientific Title Multicenter phase II trial of gemcitabine and S-1 for gallbladder cancer
Date of disclosure of the study information 2008/07/25
Last modified on 2012/07/25

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Basic information
Public title Multicenter phase II trial of gemcitabine and S-1 for gallbladder cancer
Acronym Multicenter phase II trial of gemcitabine and S-1 for gallbladder cancer
Scientific Title Multicenter phase II trial of gemcitabine and S-1 for gallbladder cancer
Scientific Title:Acronym Multicenter phase II trial of gemcitabine and S-1 for gallbladder cancer
Region
Japan

Condition
Condition gallbladder cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes efficacy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 anti-cancer drug
Interventions/Control_2
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
75 years-old >
Gender Male and Female
Key inclusion criteria The study is designed to enroll patients with nonresectable, pathologically proven, gallbladder cancer. Other eligibility criteria includes no prior therapy, performance status of 0-2.
Written informed consent is required from all patients.
Key exclusion criteria The exclusion criteria are as follows: active infection.
pregnant or lactating women, women of childbearging age.
the patient inappropriate for entry onto this study in the judgment of the investigator.

Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65,Tsuruma-Cho,Showa-Ku,Nagoya City
TEL 052-744-2602
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address
TEL 052-744-2602
Homepage URL
Email

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 25 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 Completed
Date of protocol fixation
2008 Year 02 Month 18 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2012 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 25 Day
Last modified on
2012 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001381

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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