EUCTR2021-000135-31-SE进行中（未招募）1 期
The Effect of tinzaparin on Biomarkers in FIGO Stage III-IV Ovarian Cancer Patients Undergoing Neoadjuvant Chemotherapy – A randomized pilot study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •The subject has given written consent to participate in the study.
- •Age 18 and above
- •Epithelial ovarian, fallopian tube or peritoneal cancer, or abdominal cancer where a biopsy or cytology 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.
- •Selected for NACT with platinum double regimen at a multidisciplinary conference at Department of Oncology at Linköping University Hospital
- •Receive treatment at either of the University Hospital in Linköping, or the hospitals in Jönköping (Ryhov Hospital), Eksjö (Höglandssjukhuset Eksjö), Västervik (Västervik sjukhus), Kalmar (Länssjukhuset i Kalmar), Värnamo (Värnamo sjukhus).
- •Planned for platinum doublet regimen.
- •Prior to start of NACT pregnancy should be ruled out by menstrual history or in unclear cases by a urine hCG test.
- •Women of childbearing potential should use a safe birth control method (combined hormonal contraception, progesterone only hormonal contraception, intra uterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence, male or female condom, diaphragm with spermicide).
- •WHO Performance Status 0-1
- •Weight 50-150 kg
- •CA-125-level =250 kIE/L before start of treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
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
- •Ongoing pregnancy, independent of gestational age. Breastfeeding or planned pregnancy
- •EOC disclosed at Cesarean section
- •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
- •Treatment or disease which, according to the investigator, can affect treatment or study results
- •Participation or recent participation (within the last 30 days) in a clinical study with an investigational product
- •Ongoing treatment of thromboembolic disease.
- •Thromboembolic disease within the last year.
- •Hypersensitivity to the active substance (tinzaparin) or any of the excipients.
- •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.
- •Acute gastro duodenal ulcer.
- •Septic endocarditis.
- •Previous heparin-induced thrombocytopenia.
- •WHO Performance Status >1.
- •Platinum single regimen
- •E-GFR <30ml/min (analyzed no more than 14 days before start of treatment with investigational product)
- •Platelets <50 x10^9/L (analyzed no more than 14 days before start of treatment with investigational product)
- •Other known malignancy
研究者
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