UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004359 |
|---|---|
| Receipt number | R000005210 |
| Scientific Title | A Phase I/II Trial of combined adjuvant therapy with gemcitabine and cisplatin for resected biliary tract cancer |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2024/05/22 07:16:21 |
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Basic information
Public title
A Phase I/II Trial of combined adjuvant therapy with gemcitabine and cisplatin for resected biliary tract cancer
Acronym
A Phase I/II Trial of combined adjuvant therapy with gemcitabine and cisplatin for resected biliary tract cancer
Scientific Title
A Phase I/II Trial of combined adjuvant therapy with gemcitabine and cisplatin for resected biliary tract cancer
Scientific Title:Acronym
A Phase I/II Trial of combined adjuvant therapy with gemcitabine and cisplatin for resected biliary tract cancer
Region
| Japan |
Condition
Condition
Resected biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A Phase I/II Trial of combined adjuvant therapy with gemcitabine and cisplatin for resected biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Gemcitabine and cisplatin administration
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
resected biliary tract cancer
PS 0-1
Hb>=10g/dl
WBC>=3000/mm3
Neu>=1500/mm3
Plt>=100000/mm3
AST,ALT<x3 of normal
T.bil<x2 of normal
Ccr>=45ml/min
Key exclusion criteria
Interstitial pneumonia
heart failure
ascites and edema
Infection
diabetes mellitus
Allergy of the drugs
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Miyagawa |
Organization
Shinshu University
Division name
Surgery
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2654
shinichi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahide Yokoyama |
Organization
Shinshu University
Division name
Surgery
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2654
Homepage URL
tyoko@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine, Surgery
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine, Surgery
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
| 2010 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005210
