Tinzaparin And Biomarkers After Neoadjuvant Treatment of Ovarian Cancer
- Conditions
- Epithelial ovarian cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-000135-31-SE
- Lead Sponsor
- Region Östergötland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 40
The subject has given written consent to participate in the study.
Female sex
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method