UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001206 |
|---|---|
| Receipt number | R000001463 |
| Scientific Title | Chemo-radiation for locally advanced biliary cancer |
| Date of disclosure of the study information | 2008/06/22 |
| Last modified on | 2010/12/21 09:14:11 |
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Basic information
Public title
Chemo-radiation for locally advanced biliary cancer
Acronym
Chemo-radiation for locally advanced biliary cancer
Scientific Title
Chemo-radiation for locally advanced biliary cancer
Scientific Title:Acronym
Chemo-radiation for locally advanced biliary cancer
Region
| Japan |
Condition
Condition
Unresectable and locally advanced biliary cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Phase I/II Study of chemo-radiation for locally advanced biliary 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
Radiation with Gemcitabine 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
Unresectable locally advanced bilary cancer
PS0-1
Hb>10.0
WBC 4000-12000/uL
Neu >2000/uL
PLT >100000/uL
AST, ALT <x2.5 or <x3 of normal with obstractive jaundice (OJ)
T.Bil <x2 or <x3 of normal with OJ
crtn W.N.L
Key exclusion criteria
Interstitial Pneumonia
Infection
Heart Failure
DM
Allergy
Other Severe Complications
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University, Graduate School of Medicine, Surgery
Division name
GE Surgery
Zip code
Address
Yamadaoka 2-2, Suita City, Osaka, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka University
Division name
GE Surgery
Zip code
Address
TEL
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Osaka University, Graduate School of Medicine, GE Surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka University, Graduate School of Medicine, GE Surgery
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
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 | 06 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 21 | Day |
Last modified on
| 2010 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001463
