UMIN-CTR Clinical Trial

Basic information
Public title	Effect of omega-3 fatty acids administration in adjuvant chemotherapy for biliary tract cancer: an open-label, single-arm study.
Acronym	Study of the effect of omega-3 fatty acids in biliary tract cancer
Scientific Title	Effect of omega-3 fatty acids administration in adjuvant chemotherapy for biliary tract cancer: an open-label, single-arm study.
Scientific Title:Acronym	Study of the effect of omega-3 fatty acids in biliary tract cancer
Region	Japan

Condition
Condition	Biliary tract chancer
Classification by specialty	Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We will examine the effect of omega 3 fatty acid administration on adjuvant chemotherapy completion rate in adjuvant chemotherapy with TS-1 for biliary tract cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	completion rate in adjuvant chemotherapy with TS-1
Key secondary outcomes	Detail of cholangitis Adverse effect Recurrence and prognosis Nutrition status Immune status

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	Omega-3 fatty acids administration during adjuvant chemotherapy
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) patients after resection of biliary tract cancer (2) patients pathologically diagnosed as adenocarcinoma or adenosquamous cell carcinoma and Stage2,3, and 4 (3) patients whose Performance Status is 0 or 1 (4) patients who is possible oral intake (5) patients who meet the following criteria; 1. Neut is higher or equal to 1,200/mm3 2. Plt is higher or equal to 10,000/mm3 3. Hb is higher or equal to 8.0g/dL 4. T-Bil is lower or equal to 2.0mg/dL 5. AST(GOT) is lower or equal to 100IU/L 6. ALT(GPR) is lower or equal to 100IU/L 7. Serum Cre is lower or equal to 1.2mg/dL 8. Ccr is higher or equal to 40ml/min 9. Tcho is higher or equal to 100mg/dL and TG is higher or equal to 20mg/dL 10. PT% is higher or equal to 50%, PT-INR is lower or equal to 2.0, and APTT is lower or equal to 50sec (except the patients taking warfarin) (6) patients who gained document by their own voluntary intention
Key exclusion criteria	(1) patients with severe liver or renal dysfunction (2) patients with drug hypersensitivity (3) patients judged as inappropriate by researcher
Target sample size	55

Research contact person
Last name of lead principal investigator	1st name Kimihiko Middle name Last name Ueno
Organization	Kobe University Graduate School of Medicine
Division name	Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery
Zip code	650-0017
Address	7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe
TEL	078-382-6302
Email	kueno.rhmn@gmail.com

Public contact
1st name of contact person	1st name Kimihiko Middle name Last name Ueno
Organization	Kobe University Graduate School of Medicine
Division name	Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery
Zip code	650-0017
Address	7-5-2, Kusunoki-Cho, Chuo-Ku, Kobe
TEL	078-382-6302
Homepage URL
Email	kueno.rhmn@gmail.com

Sponsor
Institute	Kobe University Graduate School of Medicine Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University clinical research ethical committee
Address	Hyogo 7-5-2, Kusunoki-cho, chuo-ku, Kobe-city, Hyogo, prefecture, JAPAN, 650-0017
Tel	078-382-6669
Email	cerb@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	RCTs051180007
Org. issuing International ID_1	jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 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	Open public recruiting
Date of protocol fixation	2018 Year 03 Month 12 Day
Date of IRB	2018 Year 03 Month 30 Day
Anticipated trial start date	2018 Year 08 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	With the enforcement of the clinical research act, the study was reviewed by the Kobe University clinical research ethical committee at October 2018. And after approval, the study was registered trial information with jRCT.

Management information
Registered date	2018 Year 02 Month 11 Day
Last modified on	2019 Year 05 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035677