Unique ID issued by UMIN | UMIN000028517 |
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Receipt number | R000027726 |
Scientific Title | A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy. (ExCAVE study) |
Date of disclosure of the study information | 2017/08/22 |
Last modified on | 2021/11/15 14:15:54 |
A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy.
(ExCAVE study)
ExCAVE study
A feasibility study of EdoXaban for the Cancer-Associated asymptomatic Venous thromboEmbolism in Japanese gastrointestinal cancer patients receiving chemotherapy.
(ExCAVE study)
ExCAVE study
Japan |
Gastrointestinal cancer: colorectal cancer, non-colorectal cancer (gastroesophageal, pancreatic, and biliary cancer)
Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Malignancy
NO
To evaluate the safety of edoxaban for treatment of incidental asymptomatic VTE in gastrointestinal cancer patients receiving chemotherapy.
Efficacy
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.
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
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.
20 | years-old | <= |
90 | years-old | >= |
Male and Female
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
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.
100
1st name | Yoshito |
Middle name | |
Last name | Komatsu |
Hokkaido University Hospital
Cancer Center
060-8648
Kita-15-Jo, Nishi-5-chome, Kita-ku, Sapporo, Hokkaido, Japan
011-716-1161
ykomatsu@ac.cyberhome.ne.jp
1st name | Michio |
Middle name | |
Last name | Nakamura |
Sapporo City General Hospital
Dept. of Gastroenterology
060-8604
1-1, Kita 11 jo Nishi 13 Chome, Chuo-ku, Sapporo, JAPAN
011-726-2211
michio.nakamura@icloud.com
HGCSG(Hokkaido Gastrointestinal Cancer Study Group)
Daiichi-Sankyo, Co. Ltd.
Profit organization
Hokkaido University Certified Review Board
Kita14 Nishi5, Kita-ku, Sapporo, Hokkaido
011-706-7934
recjimu@huhp.hokudai.ac.jp
YES
jRCTs011180030
Japan Registry of Clinical Trials
特定非営利活動法人 北海道消化器癌化学療法研究会(HGCSG)
2017 | Year | 08 | Month | 22 | Day |
Unpublished
Main results already published
2017 | Year | 06 | Month | 23 | Day |
2017 | Year | 08 | Month | 23 | Day |
2017 | Year | 10 | Month | 01 | Day |
2019 | Year | 12 | Month | 31 | Day |
2017 | Year | 08 | Month | 03 | Day |
2021 | Year | 11 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027726
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