2024-515450-24-00招募中2 期
The Effect of tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy – A randomized pilot study
Region Oestergoetland5 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 5
- 主要终点
- Level of CA-125 measured before cycles one-four of chemotherapy and preoperatively before DPDS.
研究概览
简要总结
The primary objective of the study is to evaluate the effects of tinzaparin on changes in levels of CA-125 in EOC patients who receive NACT.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy indicates an origin from the ovary, fallopian tube or peritoneum.
- •Histology diagnosis of either high grade serous carcinoma, endometroid carcinoma or clear cell carcinoma.
- •FIGO stage III-IV disease.
- •Planned for platinum doublet regimen.
- •WHO Performance Status 0-1
- •CA-125-level ≥250 kIE/L at diagnosis
- •Weight 50-150 kg
- •Age 18 and above
排除标准
- •Concomitant treatment with heparins, low molecular weight heparins, warfarin or non-vitamin K antagonist oral anticoagulants. Platelet inhibitors are allowed.
- •Treatment with heparins, low molecular weight heparins or non-vitamin K antagonist oral anticoagulants within the last year.
- •Known or suspected allergies against any product included in the study
- •Abdominal surgery or other major surgery within the last year
- •Thromboembolic disease within the last year
- •Serious hemorrhage or conditions predisposing to serious hemorrhage. Serious hemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or c) leads to transfusion of two or more units of whole blood or red blood cells.
- •Severe coagulation disorder
- •Platelets <100 x10^9/L (analyzed no more than 14 days before start of treatment with investigational product)
- •E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)
结局指标
主要结局
Level of CA-125 measured before cycles one-four of chemotherapy and preoperatively before DPDS.
Level of CA-125 measured before cycles one-four of chemotherapy and preoperatively before DPDS.
次要结局
- Levels of hemoglobin, platelets, leucocytes, CRP, albumin, IL-6 and VEGF before every cycle of chemotherapy, preoperatively before DPDS and three weeks after the last cycle of chemotherapy.
- CA-125 measured before cycles five-seven of chemotherapy and three weeks after the last cycle of chemotherapy
- The compliance to tinzaparin injections and occurrence of adverse events related to tinzaparin will be evaluated.
- Objectively confirmed VTE, i.e. pulmonary embolism, lower-limb deep vein thrombosis or upper extremity deep vein thrombosis. Death due to VTE.
研究者
Anna Karlsson
Scientific
Region Oestergoetland
研究点 (5)
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