UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009257 |
|---|---|
| Receipt number | 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 01:21:05 |
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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
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
sumi-h@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008159
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
