Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)
Conditions
Interventions
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 r
Sponsors
HGCSG(Hokkaido Gastrointestinal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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 2xULN 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
Exclusion criteria
Exclusion criteria: 1) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence 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
| Measure | Time frame |
|---|---|
| Diminution 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 | — |
Countries
Japan
Contacts
Public ContactMichio Nakamura
Sapporo City General Hospital Dept. of Gastroenterology
Outcome results
None listed