UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023906 |
|---|---|
| Receipt number | R000021475 |
| Scientific Title | Arterial infusion chemotherapy concurrent with radiation therapy followed by systemic gemcitabine and cisplatin therapy for unresectable biliary tract cancer patients; A phase2 study |
| Date of disclosure of the study information | 2016/09/02 |
| Last modified on | 2019/09/05 09:05:39 |
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Basic information
Public title
Arterial infusion chemotherapy concurrent with radiation therapy followed by systemic gemcitabine and cisplatin therapy for unresectable biliary tract cancer patients; A phase2 study
Acronym
A phase2 study of AI+RT followed by systemic GEM+CDDP therapy for unresectable biliary tract cancer patients
Scientific Title
Arterial infusion chemotherapy concurrent with radiation therapy followed by systemic gemcitabine and cisplatin therapy for unresectable biliary tract cancer patients; A phase2 study
Scientific Title:Acronym
A phase2 study of AI+RT followed by systemic GEM+CDDP therapy for unresectable biliary tract cancer patients
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and the efficacy of arterial infusion chemotherapy concurrent with radiation therapy followed by systemic gemcitabine and cisplatin therapy for un resectable biliary tract cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate, disease control rate, adverse events rate
Key secondary outcomes
Median survival, protocol treatment completion rate, CA19-9 response rate, progression-free survival, distant metastasis-free survival, 1-year survival rate, 2-year survival rate
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
Arterial infusion chemotherapy and radiation therapy
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
It has been confirmed to be biliary tract cancer by pathological examination.
Key exclusion criteria
Resectable biliary tract cancer
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikihiro Fuiya |
Organization
Asahikawa medical university
Division name
Department of Medicine Division of Gastroenterology and Hematology / Oncology
Zip code
Address
1-1, 2-1, Midorigaoka-higasi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2462
fjym@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuma Goto |
Organization
Asahikawa medical university
Division name
Department of Medicine Division of Gastroenterology and Hematology / Oncology
Zip code
Address
1-1, 2-1, Midorigaoka-higasi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2462
Homepage URL
t-gotti@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikwa Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Asahikawa Kosei General Hospital
Sapporo Higashi Tokusyukai Hospital
Asahikawa City Hospital
Japanese Red Cross Asahikawa Hospital
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
| 2016 | Year | 09 | Month | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2019 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021475
