UMIN-CTR Clinical Trial

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
Email	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
Email	t-gotti@asahikawa-med.ac.jp

Sponsor
Institute	Asahikwa Medical University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021475