NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs011180030

Registered date:25/03/2019

ExCAVE study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedGastrointestinal cancer: colorectal cancer, non-colorectal cancer
Date of first enrollment02/10/2017
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)The edoxaban (Lixiana) is orally administered as a once-daily dosing within three days before enrollment. The once-daily starting dose is 60mg.For patients with one or more factors that increase the risk of bleeding, such as renal impairment (CrCl 15-50mL/min), low body weight (under 60 kg), concomitant use of P-gp inhibitors (e.g. cyclosporine, dronedarone, ketoconazole, erythromycin), the dose is reduced by half.

Outcome(s)

Primary OutcomeIncidence of major bleeding and clinically relevant non-major bleeding during 3 months after enrollment. Major bleeding events included those that were fatal; occurred in a critical area or organ (eg, intracranial); or caused a fall in hemoglobin of 2 g/dL or more or led to a transfusion of 2 or more units of whole blood or red cells. All non-major bleeding events that required any medical or surgical intervention were classified as clinically relevant non-major bleeding.
Secondary OutcomeDiminution rate of VTE during 3 months after enrollment. Time to diminution of VTE Total amounts of edoxaban Incidence of newly symptomatic/asymptomatic VTE Subgroup analysis: Site of TE, dose of edoxaban, site of primary cancer, renal function, body weight, age

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 90age old
GenderBoth
Include criteria1) Histologically confirmed adenocarcinoma in colorectal or non-colorectal cancers, including esophageal, gastric, pancreatic, and biliary cancer. 2) Newly diagnosed, incidental, asymptomatic deep-vein thrombosis involving the popliteal, femoral, or iliac veins or asymptomatic pulmonary embolism during GIC chemotherapy. 3) Identified with no VTE cases at the time of induction of chemotherapy by pre-screening test. 4) Patients 20 years of age or older and 90 years or younger are eligible at the time of informed consent. 5) Written informed consent to participate as a subject in this clinical study. 6) The following bone marrow, liver, and kidney function parameters measured within 14 days prior to enrollment: i) Neutrophil count: over 1500/uL ii) Platelet count: over 75000/uL iii) Hemoglobin: over 7.0 g/dL iv) Total bilirubin: under 1.5 mg/dL v) AST,ALT levels: under 2 x ULN vi) serum creatinine levels: < 1.5 mg/dL 7) ECOG PS of 0 to 2 8) Life expectancy of at least 90 days after enrollment
Exclude criteria1) Symptomatic VTE or PE at the time of diagnosed. 2) Patients who had received thrombectomy, IVC filter catheterization, and any other anticoagulant therapy. 3) In investigator's decision that the case need to be treated as acute VTE. 4) No prior screening tests for the presence of venous thromboembolic disease was performed, such as computer tomography and/or venous ultrasonography. 5) Planned treatment with a vitamin K antagonist. 6) Patients who had received treatment for more than 72 hours with therapeutic doses of heparin, low-molecular-weight heparin, more than twice dose of a vitamin K antagonist. 7) Active bleeding 8) Having several high risk factor of VTE within 3 months. 9) Known protein C or S deficiency, antithrombin deficiency, hyperhomocysteinemia, and anti-phospholipid antibody syndrome. 10) Severe hypertension which have poorly controlled despite the medication. 11) continued to receive treatment with NSAIDs except an aspirin at a dose of more than four days a week. 12) continued to receive treatment with aspirin at a dose of more than 100mg daily or dual antiplatelet therapy. 13) contined to receive treatment with dronedarone. 14) Renal dysfunction (CCR under 30mL/min) 15) Accumulation of pleural, ascitic, or pericardial fluid requiring drainage 16) Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure). Any of the following events within the 24 weeks prior to enrollment. 17) Serious hypersensitivity to any drug. 18) Current severe liver disease. 19) Active infection and/or inflammatory diseases. 20) Severe cardiac failure (over NYHA II) 21) Ineligible for participating in this study according to the investigator.

Related Information

Contact

Public contact
Name Yasuyuki Kawamoto
Address Kita 14 jo, Nishi 5 chome, Kita-ku, Sapporo, Hokkaido Hokkaido Japan 060-8648
Telephone +81-11-706-5657
E-mail y-kawamoto0716@hotmail.co.jp
Affiliation Hokkaido University Hospital
Scientific contact
Name Yoshito Komatsu
Address Kita 14 jo, Nishi 5 chome, Kita-ku, Sapporo, Hokkaido Hokkaido Japan 060-8648
Telephone +81-11-706-5657
E-mail ykomatsu@ac.cyberhome.ne.jp
Affiliation Hokkaido University Hospital