An observational study for incidence of thromboembolism in lung cancer patients. (Rising-VTE study)
- Conditions
- Non-small cell lung cancer, small cell lung cancer
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1000
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Symptomatic VTE incidence rate 2 years Symptomatic VTE incidence rate in 2 years after this study registration
symptomatic / asymptomatic VTE relapse rate 6 months symptomatic / asymptomatic VTE relapse rate for 6 months after start of oral administration of Edoxaban
- Secondary Outcome Measures
Name Time Method incidence of asymptomatic VTE incidence and symptomatic / asymptomatic arterial thrombosis 2 years after this study registration The incidence of asymptomatic VTE incidence and symptomatic / asymptomatic arterial thrombosis 2 years after this study registration
incidence rate of bleeding events 2 years after this study registration The incidence rate of bleeding events in 2 years after this study registration
Incidence of hemorrhagic events during 6 months after starting of Edoxaban oral 6 months after starting of Edoxaban oral Incidence of hemorrhagic events during 6 months after starting of Edoxaban oral
incidence of hemorrhagic events 6 months after the study registration The incidence of hemorrhagic events during the 6 months after the study registration
symptomatic VTE incidence rate 6 months after the study registration The symptomatic VTE incidence rate for 6 months after the study registration
overall survival time The overall survival time
symptomatic / asymptomatic VTE incidence and symptomatic / asymptomatic arterial thrombosis 2 years after this study registration 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 2 years after this study registration The incidence of hemorrhagic events in 2 years after this study registration
Asymptomatic VTE incidence rate and incidence of symptomatic / asymptomatic artery thrombosis 2 years after this study registration Asymptomatic VTE incidence rate and incidence of symptomatic / asymptomatic artery thrombosis in 2 years after this study registration
incidence rate of bleeding event 2 years after this study registration incidence rate of bleeding event in 2 years after this study registration
The incidence of hemorrhagic events for 6 months 6 months after starting administration of Edoxaban The incidence of hemorrhagic events for 6 months after starting administration of Edoxaban
the symptomatic VTE incidence rate for 6 months after start of Edoxaban oral administration 6 months after start of Edoxaban oral administration the symptomatic VTE incidence rate for 6 months after start of Edoxaban oral administration