UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015450 |
|---|---|
| Receipt number | R000017963 |
| Scientific Title | Safety and efficacy of surgery following chemoradiation therapy in biliary tract cancer patients. |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2016/02/10 15:50:13 |
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Basic information
Public title
Safety and efficacy of surgery following chemoradiation therapy in biliary tract cancer patients.
Acronym
Surgery following chemoradiation in BTC patients.
Scientific Title
Safety and efficacy of surgery following chemoradiation therapy in biliary tract cancer patients.
Scientific Title:Acronym
Surgery following chemoradiation in BTC patients.
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of surgery following chemoradiation in biliary tract cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Efficacy of chemoradiation
(2) Safety of surgery following chemoradiation
(3) Efficacy of surgery following chemoradiation
Key secondary outcomes
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
| Maneuver | Other |
Interventions/Control_1
chemoradiation and surgery
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
1. PS 0-1
2.1 Neutrophil>= 1,000 /mm3
2.2 Platelet>= 70,000 /mm3
2.3 Hb>= 8.0 g/dL
2.4 AST and ALT=< 400 U/L
2.5 Bilirubin=< 3.0 mg/dL*
2.6 creatinin=< 1.5 mg/dL
2.7 clinically normal ECG for surgery
3. written informed consent
Key exclusion criteria
(1) possible R2 resection
(2) estimated residual liver volume < 35%, after portal embolization
(3) others
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 Cardiovascular Diseases
Division name
Surgery
Zip code
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka city, Osaka 537-8511, Japan
TEL
06-6972-1181
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 Cardiovascular Diseases
Division name
Surgery
Zip code
Address
Nakamichi 1-3-3, Higashinari-ku, Osaka city, Osaka 537-8511, Japan
TEL
06-6972-1181
Homepage URL
s-kobayashi@umin.ac.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
YES
Study ID_1
1408271143
Org. issuing International ID_1
Osaka Medical Center for Cancer and Cardiovascular Diseases
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
| 2014 | Year | 11 | Month | 01 | 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
Anticancer Res. 2016 Jan;36(1):335-42.
Cancer Chemother Pharmacol. 2015 Dec;76(6):1191-8. doi: 10.1007/s00280-015-2908-3. Epub 2015 Nov 7.
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
Main results already published
Date of protocol fixation
| 2014 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 16 | 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
| 2014 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017963
| 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 |
