UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031247
Receipt No. R000035677
Scientific Title Effect of omega-3 fatty acids administration in adjuvant chemotherapy for biliary tract cancer: an open-label, single-arm study.
Date of disclosure of the study information 2018/03/20
Last modified on 2019/05/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.