UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043850 |
|---|---|
| Receipt number | R000049919 |
| Scientific Title | Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer |
| Date of disclosure of the study information | 2021/04/06 |
| Last modified on | 2023/07/29 12:10:36 |
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Basic information
Public title
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Acronym
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Scientific Title
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Scientific Title:Acronym
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the drug interaction (anti-Xa activity) between edoxaban, which is used for the treatment of venous thromboembolism (VTE) and prevention of recurrence, or for the prevention of stroke and systemic embolism in patients with atrial fibrillation, and anticancer drugs used in the treatment of colorectal cancer, and the safety of the combination.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Anti-Xa activity in the blood during chemotherapy for colorectal cancer
Key secondary outcomes
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) Patients undergoing or scheduled to undergo chemotherapy for advanced or recurrent colorectal cancer
2) Patients diagnosed with deep vein thrombosis (DVT) by lower limb vein echography (symptomatic or asymptomatic) or pulmonary artery thromboembolism (PTE) by chest contrast CT scan (symptomatic or asymptomatic) who are already taking edoxaban.
3) Patients with paroxysmal atrial fibrillation who are already taking edoxaban to prevent stroke or systemic embolism.
4) Patients aged 20 years or older
(5) Performance status (PS: index of patient's general condition) is 0 to 2 according to ECOG criteria.
(6) Patients who can obtain written consent from the patient.
(2) and (3) are either satisfied.
Key exclusion criteria
(1) Patients who are bleeding
(2) Patients with complications that may cause bleeding
3) Patients using heparin, low molecular weight heparin, danaparoid, antithrombin (argatroban, etc.), oral anticoagulant (warfarin), thrombolytic, antiplatelet agents (ticlopidine, clopidogrel, aspirin, etc.)
Patients who are taking strong inducers or inhibitors of CYP3A4.
(5) Patients who do not have major organ function.
Patients who do not meet any of the following criteria
(6) Patients with a known history of hypersensitivity to any component of the study drug or any drug used in the chemotherapy regimen
(7) Patients with a history of cerebral hemorrhage
(viii) Patients with contrast media allergy
(9) Patients with acute bacterial endocarditis
(10) Patients for whom edoxaban cannot be administered according to the package insert
(11) Other patients deemed inappropriate for the study by the principal investigator or sub-investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masataka |
| Middle name | |
| Last name | Ikeda |
Organization
Hyogo College of Medicine
Division name
Division of lower GI, department of surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6372
ms-ikeda@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Jihyung |
| Middle name | |
| Last name | Song |
Organization
Hyogo College of Medicine
Division name
Division of lower GI, department of surgery
Zip code
663-8501
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6372
Homepage URL
ch-son@hyo-med.ac.jp
Sponsor or person
Institute
Division of lower GI, department of surgery, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka International Cancer Institute
Kansai Rosai Hospital
Ikeda City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 06 | 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
| 2020 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective non-interventional observational study
Management information
Registered date
| 2021 | Year | 04 | Month | 06 | Day |
Last modified on
| 2023 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049919
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