UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031247 |
|---|---|
| Receipt number | 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 08:56:22 |
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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
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
kueno.rhmn@gmail.com
Sponsor or person
Institute
Kobe University Graduate School of Medicine Department of Surgery Division of Hepato-Biliary-Pancreatic Surgery
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035677
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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