UMIN-CTR Clinical Trial

Basic information
Public title	Prospective research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Acronym	A research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Scientific Title	Prospective research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Scientific Title:Acronym	A research of the biomarkers associated with adjuvant chemotherapy in patients with resectable biliary tract cancer
Region	Japan

Condition
Condition	Biliary tract cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify the biomarkers which correlate with the efficacy of adjuvant chemotherapy for biliary tract cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relapse-free survival
Key secondary outcomes	Overall survival

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Surgicaly resected and histologically proven ductal pancreatic cancer 2) Age of more than 20 years Oral intake is possible 3) ECOG performance status (PS) of 0 to 2 4) Oral intake is possible 5) Adequate organ function 6) Written informed
Key exclusion criteria	1)Intestinal pneumonia or lung fibrosis 2) No previous adjuvant therapy 3) Severe diarrhea 4) Severe mental disorder 5) Active infection 6) Severe complication disease 7) Sever postoperative complications 8) History of chest radiotherapy 9) intractable pleural or abdominal effusion 10) Distant metastasis 11) History of other active malignancy 12) Pregnacy or patient's hope to be pregnant 13) Inadequate physical condition, as diagnosed by primary physician
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Nobuhiro Middle name Last name Shibata
Organization	University of Miyazaki Hospital
Division name	Department of Medical Oncology
Zip code	889-1692
Address	5200 Kihara, Kiyotake, Miyazaki, 889-1692, JAPAN
TEL	0985-85-1419
Email	n-shiba@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Nobuhiro Middle name Last name Shibata
Organization	University of Miyazaki Hospital
Division name	Department of Medical Oncology
Zip code	889-1692
Address	5200 Kihara, Kiyotake, Miyazaki, 889-1692, JAPAN
TEL	0985-85-1419
Homepage URL
Email	n-shiba@med.miyazaki-u.ac.jp

Sponsor
Institute	Department of Medical Oncology, University of Miyazaki Hospital
Institute
Department

Funding Source
Organization	Yakult Honsha Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Yakult Honsha Co., Ltd Yakult Central Institute
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	University of Miyazaki Hospital, Clinical Research Support Center
Address	5200 Kihara, Kiyotake, Miyazaki, 889-1692, Japan
Tel	0985-85-9010
Email	igakubu_kenkyu@med.miyazaki-u.ac.jp

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	宮崎大学医学部附属病院（宮崎県）

Other administrative information
Date of disclosure of the study information	2010 Year 11 Month 24 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	50
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	Terminated
Date of protocol fixation	2009 Year 07 Month 01 Day
Date of IRB	2009 Year 07 Month 01 Day
Anticipated trial start date	2009 Year 07 Month 01 Day
Last follow-up date	2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective study

Management information
Registered date	2010 Year 11 Month 24 Day
Last modified on	2020 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005507