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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009257
Receipt No. R000008159
Scientific Title Phase II study of gemcitabine + cisplatin in patients with unresectable advanced gallbladder cancer. Multicenter study
Date of disclosure of the study information 2012/11/04
Last modified on 2013/12/12

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Basic information
Public title Phase II study of gemcitabine + cisplatin in patients with unresectable advanced gallbladder cancer. Multicenter study
Acronym Phase II study of gemcitabine + cisplatin in patients with unresectable advanced gallbladder cancer. Multicenter study
Scientific Title Phase II study of gemcitabine + cisplatin in patients with unresectable advanced gallbladder cancer. Multicenter study
Scientific Title:Acronym Phase II study of gemcitabine + cisplatin in patients with unresectable advanced gallbladder cancer. Multicenter study
Region
Japan

Condition
Condition unresectable advanced gallbladder cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 to clarify the efficacy and safety of Gemcitabine and CDDP in patients with unresectable advanced gallbladder cancer.
Basic objectives2 Others
Basic objectives -Others toxicity of gemcitabine/CDDP
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Time to progression,safety

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 chemotherapy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria the patients of the gallbladder cancer with unresectable local progression or remote metastasis by imaging diagnosis in Nagoya University digestive organ internal medicine and a Nagoya University-affiliated institution and agreed our study.
Key exclusion criteria (1)interstitial pneumonia or pulmonary fibrosis(2)a case with uncontrolable diabetes,liver damage angina pectoris or acute myocardial infarction within three months(3)sever infection(4)brain metastasis with symptons(5)overlap cancer(6)sever edema,Ascites,pleural effusion(7) Case with possibility of pregnancy,during nursing(8)sever drug allergy(9)sever complications(10) In addition, the case judged to be inappropriate for the examination to carry out this study safely
Target sample size 50

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 tsurumai-cho,syowaku,Nagoyasity
TEL 052-744-2602
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hajime Sumi
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 1-1 2-chome,Kawana-cho,showa-ku,Nagoya
TEL 052-744-2602
Homepage URL
Email sumi-h@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Graduate Schoolof medicine
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
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
2012 Year 11 Month 04 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
9 patients are now enrolled.
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 Open public recruiting
Date of protocol fixation
2011 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 08 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
2012 Year 11 Month 04 Day
Last modified on
2013 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008159

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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