UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022562 |
|---|---|
| Receipt number | R000024561 |
| Scientific Title | Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/06/08 22:42:41 |
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Basic information
Public title
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Acronym
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Scientific Title
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Scientific Title:Acronym
Phase I trial of weekly gemcitabine with radiotherapy for unresectable locally advanced biliary tract cancer.
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to evaluate the safety of gemcitabine combined with radiotherapy, and to decide the recommended dose.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse events within two weeks after treatment.
Key secondary outcomes
Maximum tolerated dose, toxicity
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
Chemoradiotherapy (with gemcitabine)
Radiotherapy : total 50.4Gy/28Fr. Once a day ( 1.8Gy/day), five times a week.
Gemcitabine : div day1,8,15,22,29,36
Increase the dose of gemcitabine : 400mg/m2, 500mg/m2, 600mg/m2
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Unresectable locally advanced biliary tract cancer
Key exclusion criteria
No previous history of treatment.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihiro Ono |
Organization
Sapporo medical university
Division name
department of medical oncology
Zip code
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
onomichihiro34@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michihiro Ono |
Organization
Sapporo medical university
Division name
department of medical oncology
Zip code
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
onomichihiro34@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university, department of medical oncology
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
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
札幌医科大学（北海道）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | 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
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | 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 | 06 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024561
