JPRN-jRCTs061180025已完成未知
An observational study for incidence of thromboembolism in lung cancer patients, and the evaluation for efficacy and safety of edoxaban in active cancer patients with venous thromboembolism. - Rising-VTE study
ISOBE Takeshi0 个研究点目标入组 1,021 人开始时间: 2019年2月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,021
研究概览
简要总结
we conclude attention should be paid to VTE during treatment for lung cancer. Second, treatment with edoxaban was highly effective in preventing recurrence of VTE, but treatment should be considered more carefully because of the high bleeding possibility.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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