Study Title: The TABANETOC Trial
Objective: Evaluating the Anti-Neoplastic Effects of Tinzaparin in EOC Patients
Background: Tinzaparin, a low-molecular weight heparin (LMWH), has demonstrated anti-neoplastic properties in animal models and in vitro studies of human cancer cell lines. Reduction in CA-125 levels during neoadjuvant chemotherapy (NACT) in patients with epithelial ovarian cancer (EOC) is associated with a better prognosis.
Purpose: Investigate changes in serum CA-125 levels in advanced EOC patients receiving NACT to evaluate the potential anti-neoplastic effects of tinzaparin.
Method: Open randomized multicenter pilot trial with 40 EOC patients receiving NACT randomized 1:1 to receive daily tinzaparin or no tinzaparin. Biomarkers, including CA-125, will be measured before every cycle of chemotherapy, preoperatively, and 3 weeks after the last cycle of chemotherapy.
Patients: Inclusion criteria: women aged 18 years or older, WHO performance status 0-1, histologically confirmed high-grade serous, endometrioid or clear cell EOC, FIGO stages III-IV, and CA-125 level of ≥ 250 kIE/L at diagnosis. Exclusion criteria: contraindications to LMWH, ongoing or recent treatment with specific anticoagulants.
Interpretation: This study will contribute to understanding the anti-neoplastic effects of tinzaparin in EOC patients and may guide future research on the impact of tinzaparin on survival in EOC.
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