Unique ID issued by UMIN | UMIN000043850 |
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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 |
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Evaluation for the safety of a novel oral Xa inhibitor in combination with chemotherapy in patients with advanced or recurrent colorectal cancer
Japan |
colorectal cancer
Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Malignancy
NO
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.
Safety
Anti-Xa activity in the blood during chemotherapy for colorectal cancer
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
(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.
50
1st name | Masataka |
Middle name | |
Last name | Ikeda |
Hyogo College of Medicine
Division of lower GI, department of surgery
663-8501
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
0798-45-6372
ms-ikeda@hyo-med.ac.jp
1st name | Jihyung |
Middle name | |
Last name | Song |
Hyogo College of Medicine
Division of lower GI, department of surgery
663-8501
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
0798-45-6372
ch-son@hyo-med.ac.jp
Division of lower GI, department of surgery, Hyogo College of Medicine
DAIICHI SANKYO COMPANY
Profit organization
Osaka International Cancer Institute
Kansai Rosai Hospital
Ikeda City Hospital
Hyogo College of Medicine
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
0798-45-6066
rinri@hyo-med.ac.jp
NO
2021 | Year | 04 | Month | 06 | Day |
Unpublished
Open public recruiting
2020 | Year | 12 | Month | 08 | Day |
2021 | Year | 01 | Month | 21 | Day |
2021 | Year | 04 | Month | 06 | Day |
2023 | Year | 12 | Month | 31 | Day |
A prospective non-interventional observational study
2021 | Year | 04 | Month | 06 | Day |
2023 | Year | 07 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049919
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