JRCT ID: jRCTs061180025
Registered date:20/02/2019
An observational study for incidence of thromboembolism in lung cancer patients.
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Non-small cell lung cancer, small cell lung cancer |
Date of first enrollment | 02/06/2016 |
Target sample size | 1000 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | edoxaban 60 or 30mg/day for 6 months |
Outcome(s)
Primary Outcome | VTE noncompliant group (observation group): Symptomatic VTE incidence rate in 2 years after this study registration. VTE merger group (treatment intervention group): symptomatic / asymptomatic VTE relapse rate for 6 months after start of oral administration of Edoxaban. |
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Secondary Outcome | VTE noncompliant group (observation group): The incidence of asymptomatic VTE incidence and symptomatic / asymptomatic arterial thrombosis 2 years after this study registration, the incidence rate of bleeding events in 2 years after this study registration, The incidence of hemorrhagic events during the 6 months after the study registration, the symptomatic VTE incidence rate for 6 months after the study registration, the overall survival time. VTE merger group (treatment intervention group): Incidence of hemorrhagic events during 6 months after starting of Edoxaban oral symptomatic / asymptomatic VTE incidence and symptomatic / asymptomatic arterial thrombosis 2 years after this study registration , The incidence of hemorrhagic events in 2 years after this study registration, overall survival time. VTE consolidated observation group: Asymptomatic VTE incidence rate and incidence of symptomatic / asymptomatic artery thrombosis in 2 years after this study registration, incidence rate of bleeding event in 2 years after this study registration, after starting administration of Edoxaban The incidence of hemorrhagic events for 6 months, the symptomatic VTE incidence rate for 6 months after start of Edoxaban oral administration, the overall survival time. |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1)Pathologically or cytologically diagnosed non-small-cell or small cell lung cancer. 2)ECOG PS 0-3. 3)Age over 20 years old. 4)It satisfies one of the following. Small cell lung cancer of ED-stage. Non-small-cell lung cancer of stage IIIB or IV. Reccurence of operation or concurrent chemoradiotherapy. Best supportive care patient. 5)6 months or longer expected survival. 6)Written informed consent. |
Exclude criteria | 1)History of allergic reaction for edoxavan. 2)Severe renal dysfunction. (Ccr under 30 mL/min) 3)Severe liver disease. 4)Interstitial pneumonia. 5)Plannning for concurrent chemoradiotherapy. 6)Started medication or treatment for VTE. 7)More than 48 hours of anticoagulant (LMWH, UFH, fondaparinux or VKA, Edoxaban etc) was administered to the most recently diagnosed VTE. 8)ALT is more than twice the facility reference value or T-Bil is more than 1.5 times the facility reference value. 9)Active bleeding. 10)Severe hypertention. 11)A pregnant woman, a woman in breast-feeding. 12)Taking aspirin or two kind os antiplatelet drug. 13)Acute infectious endocarditis. 14)An inappropriate case judged by doctor in charge. |
Related Information
Primary Sponsor | ISOBE Takeshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | Daiichi Sankyo Company, Limited,Daiichi Sankyo Company, Limited |
Secondary ID(s) | UMIN000020194 |
Contact
Public contact | |
Name | Yukari TSUBATA |
Address | 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501 |
Telephone | +81-853-20-2578 |
ytsubata@med.shimane-u.ac.jp | |
Affiliation | Shimane University Hospital |
Scientific contact | |
Name | Takeshi ISOBE |
Address | 89-1, Enya-cho, Izumo-shi, Shimane Shimane Japan 693-8501 |
Telephone | +81-853-20-2578 |
isobeti@med.shimane-u.ac.jp | |
Affiliation | Shimane University Hospital |