UMIN-CTR Clinical Trial

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
Email	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
Email	ch-son@hyo-med.ac.jp

Sponsor
Institute	Division of lower GI, department of surgery, Hyogo College of Medicine
Institute
Department

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
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
Email	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	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049919

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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