UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020964 |
|---|---|
| Receipt number | R000024189 |
| Scientific Title | Neoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancer |
| Date of disclosure of the study information | 2016/02/11 |
| Last modified on | 2016/08/11 10:38:23 |
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Basic information
Public title
Neoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancer
Acronym
Neoadjuvant chemoradiation therapy for biliary tract cancer
Scientific Title
Neoadjuvant chemoradiation combined with gemcitabine and cisplatin for biliary tract cancer
Scientific Title:Acronym
Neoadjuvant chemoradiation therapy for biliary tract cancer
Region
| Japan |
Condition
Condition
resectable biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of neoadjuvant chemoradiation therapy combined with gemcitabine and cisplation for biliary tract cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety, Recommended dose (RD), Effect of neoadjuvant chemoradiation. Safety and RD will be evaluated using CTCAE and determined by DLT. Effect will be radiologically and pathologically evaluated.
Key secondary outcomes
Resection rate, R0 resection rate, Recurrent free survival, Overall survival
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
Neoadjuvant chemoradiation therapy combined with gemcitabine and cisplatin
gemcitabine 1000mg/m2 - 600mg/m2
cisplatin 25mg/m2 - 20mg/m2
day 1, 8 every 3 weeks, 3 course
radiation 50-60 Gy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Resectable biliary tract cancer (including intrahepatic cholangiocarcinoma)
Major organ function (bone marrow, heart, liver, lung, kidney, etc) are maintained.
Written informed consent
Key exclusion criteria
R2 resection
Estimated remnant liver volume would be less than 35%
Active double cancer
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Division name
Surgery
Zip code
Address
1-3-3, Nakamochi, Higashinari, Osaka, 537-8511, Japan.
TEL
+81-6-6972-1181
s-kobayashi@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Division name
Surgery
Zip code
Address
1-3-3, Nakamochi, Higashinari, Osaka, 537-8511, Japan.
TEL
+81-6-6972-1181
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovasuclar diseasese
Organization
Division
Category of Funding Organization
Local Government
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
大阪府立成人病センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 11 | 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
| 2016 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 04 | 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
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2016 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024189
| 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 |
