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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043850

Enrollment

Registered

2021-04-06

Start date

2021-04-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Anti-Xa activity in the blood during chemotherapy for colorectal cancer	—

Countries

Japan

Contacts

Public ContactJihyung Song

Hyogo College of Medicine Division of lower GI, department of surgery

ch-son@hyo-med.ac.jp0798-45-6372

Outcome results