Prophylaxis of venous thromboembolic disease with LMWH (TINzaparin) in patients with metastatic colorectal cancer who start the first line of treatment.
EU CTIS ID: 2023-508860-31-00
What this study is testing
The main objective of the study is to evaluate the efficacy of 4-months prophylaxis with LMWH (tinzaparin) for the prevention of symptomatic or incidental VTE events in patients with stage IV colorectal cancer (mCRC) that initiate first line systemic treatment (ChT +/- targeted therapy).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female subjects with age ≥ 18 years. 2. Written informed consent. 3. Patients with a histologically confirmed diagnosis of stage IV colon or rectal adenocarcinoma (mCRC). 4. Locally assessed BRAF and RAS genomic alterations available during screening. 5. Beginning of the first line of treatment for metastatic disease with chemotherapy +/- targeted therapy (i.e. antiangiogenic, anti-EGFR, encorafenib-cetuximab doublet) or immunotherapy. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Life expectancy >6 months.
You likely can't join if
- 1. Contraindication to tinzaparin, or other heparins: a. Allergy (or hypersensitivity) to heparin, tinzaparin, other LMWHs, or pork products. b. History or presence of heparin-induced (type II) thrombocytopenia. c. Have or have had an epidural catheter or a traumatic spinal puncture within the previous 7 days. 2. Prothrombin time (PT) (International normalized ratio [INR] >1.5 for any reason) or aPTT >2 times control value. 3. Active or recent (<3 months) major bleeding or conditions predisposing to major bleeding. A major bleeding is defined as one that meets one of the following three criteria: a. occurring in a critical area or organ (for example, intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular or pericardial, intrauterine or intramuscular with compartment syndrome), b. causing a decrease in hemoglobin levels of 2 g/l (1.24 mmol/l) or more, or c. that requires a transfusion of two or more units of whole blood or packed red blood cells. 4. Lesions or conditions at increased risk of clinically significant bleeding, including: a. Previously diagnosed/treated VTE ≤ 28 days prior to randomization. b. Active ulcer disease. c. Diagnosed cerebral metastases. d. Stroke within the prior 6 months. e. History of central nervous system (CNS) or intraocular bleeding. 5. Requirement of other anticoagulant therapy, dual antiplatelet therapy, daily non-steroidal anti-inflammatory drugs, or other medications known to increase the risk of bleeding. Note: A daily dose of ≤100 mg of aspirin and single agent clopidogrel are permitted 6. Acute or chronic renal insufficiency with Creatinine clearance < 30 ml / min. 7. Platelet count < 80.000 /μl at the time of inclusion. 8. Severe liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including: a. elevated levels of total bilirubin (> 2 times the upper limit normal [ULN]), b. elevated liver transaminases ALT or AST (> 2 times the ULN; > 5 in case of hepatic metastasis). 9. Participating in another study of an investigational agent at the time of enrollment. Note: Use of an experimental regimen of an approved product is not cause for exclusion. 10. Patients who weigh < 50 Kg. 11. Women of childbearing potential (WOCBP), must provide a negative serum or urine pregnancy test at screening. Women breastfeeding are not eligible. Note: A pregnancy test is performed on WOCBP as per standard of care for patients undergoing anticancer treatments. 12. Any underlying medical or psychiatric disorder, which, in the opinion of the investigator, makes the administration of tinzaparin unsafe or interferes with the informed consent process or trial procedures.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.