JPRN-jRCTs051190024已完成未知
Clinical trial for assessing the safety of edoxaban with chemotherapy to the patients with gynecologic cancer-associated thrombosis by measuring its blood concentration - EGCAT study
Sawada Kenjiro0 个研究点目标入组 16 人开始时间: 2019年6月3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
- 16
研究概览
简要总结
In CAT patients with ovarian or uterine corpus cancer who are taking oral edoxaban, no significant increase in trough concentration of edoxaban was observed when they received chemotherapy, suggesting the safety of edoxaban usage during the treatment of gynecological cancers.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 84age old（—）
- 性别
- Female
入选标准
- •1. Pathohistologically diagnosed with ovarian or uterus corpus cancer
- •2. Confirmed venous thrombosis in hematology test (D-dimer) and image test (lower limb venous ultrasound and/or contrast-enhanced computed tomography)
- •3. Female subjects with age more than or equal to 20 years and less than 85 years
- •4. First line chemotherapy after operation
- •5. Any chemotherapies of following were selected
- •TC( Paclitaxel plus Carboplatin)
- •Dose dense TC
- •TC pulse Bevacizumab
- •TEC (Paclitaxel plus Epirubicin pulse Carboplatin)
- •6. An Eastern Cooperative Oncology Group Performance Status of 0 to 2 at the time of informed consent
- •7. Life expectancy more than 6 months from the time of informed consent
- •8. Able to consent this study by oneself and provide written informed consent
排除标准
- •1. Creatinine clearance (Cockcroft-Gault) less than 30mL/min
- •2. Concurrent transaminase (AST or ALT more than and equal to 80U/L) and total bilirubin (more than and equal to 1.8 mg/dL) elevation in the absence of a clinical explanation
- •3. Body weight less than 40kg
- •4. Active bleeding on the day of informed consent or with particularly high bleeding risk
- •5. Patients with uncontrollable high blood pressure (systolic blood pressure more than and equal to 170mmHg or diastolic blood pressure more than and equal to110mmHg in the case of using antihypertensive drug)
- •6. History of allergy to Direct oral anticoagulants (DOACs)
- •7. Patients who are pregnant, breastfeeding, or with wish for a baby
- •8. Treatment with aspirin in a dosage of more than or equal to 100mg per day or dual antiplatelet therapy (any 2 antiplatelet agents including aspirin plus any other oral or intravenous antiplatelet drug) anticipated to continue during study
- •9. History of venous thrombosis
- •10. Patients with complications of acute bacterial endocarditis
- •11. Patients with history of atrial fibrillation or complications of atrial fibrillation
- •12. Considered ineligible for other reasons by the investigators
研究者
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