Prevention of Venous and Arterial Thromboembolism, in Cancer Patients Undergoing Chemotherapy, With a Low Molecular Weight Heparin (Nadroparin Calcium)
- Conditions
- Advanced CancerMetastatic Cancer
- Interventions
- Drug: saline solution (placebo)
- Registration Number
- NCT00951574
- Lead Sponsor
- Italfarmaco
- Brief Summary
In this phase III, multicenter study, 1200 patients with lung, breast, gastrointestinal (stomach, colon-rectum, pancreas), ovarian or head and neck cancer undergoing chemotherapy will be randomly assigned (at the beginning of cytotoxic therapy) in a 2:1 ratio and in double-blind conditions to a treatment with subcutaneous low molecular weight heparin (nadroparin calcium, one injection/day) or placebo for the overall duration of chemotherapy or up to a maximum of 4 months (+/- 10 days).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1166
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description saline solution saline solution (placebo) Pre-filled syringes of 0.4 ml, 1 subcutaneous injection/day (every 24 hours). nadroparin calcium Nadroparin calcium Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
- Primary Outcome Measures
Name Time Method Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy Events occurring during the four months of treatment plus 10 days
- Secondary Outcome Measures
Name Time Method Survival, at the end of study treatment Events occurring during the four months of treatment plus 10 days Response to chemotherapy Events occurring during the four months of treatment plus 10 days For patients with central venous catheters (CVC), complications of possible thrombotic origin, such as malfunction or requirement of CVC removal Events occurring during the four months of treatment plus 10 days Superficial thrombophlebitis of lower limbs Events occurring during the four months of treatment plus 10 days Asymptomatic thromboembolic events diagnosed during tests performed for other purposes Events occurring during the four months of treatment plus 10 days Safety (major bleeding, minor bleeding, other adverse events) Events occurring during the four months of treatment plus 48 hours
Trial Locations
- Locations (25)
Salvatore Maugeri Foundation
🇮🇹Pavia, Italy
Hematology and Oncology Department
🇮🇹Piacenza, Italy
Medical Oncology Department Regina Elena Institute
🇮🇹Roma, Italy
Medical Oncology Department - University of Pisa
🇮🇹Pisa, Italy
Oncology Department Molinette Hospital
🇮🇹Torino, Italy
Gynecology Oncology INT
🇮🇹Milano, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Casa Sollievo dell Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Medical Oncology Department Istituto Oncologico Veneto
🇮🇹Padova, Italy
Medical Oncology Department - Businco Hospital
🇮🇹Cagliari, Italy
Medical Oncology Department Careggi Hospital
🇮🇹Firenze, Italy
Medical Oncology Department Policlinico
🇮🇹Milano, Italy
Medical Oncology Department San Carlo Hospital
🇮🇹Milano, Italy
Medical Oncology Department 3 Regina Elena Cancer Institute
🇮🇹Rome, Italy
Onco-gynecology Department - Catholic University
🇮🇹Rome, Italy
Medical Oncology Department - S Filippo Hospital
🇮🇹Roma, Italy
Medical Oncology Department
🇮🇹Viterbo, Italy
Medical Oncology Department San Luigi Hospital
🇮🇹Orbassano, Torino, Italy
Medical Oncology Unit
🇮🇹Bergamo, Italy
Medical Oncology Department Oncology Institute
🇮🇹Bari, Italy
Medical Oncology Department - Bellaria Hospital
🇮🇹Bologna, Italy
University Bicocca
🇮🇹Milano, Italy
Medical Oncology Department University of Cagliari
🇮🇹Cagliari, Italy
Medical Oncology Department Fatebenefratelli Hospital
🇮🇹Milano, Italy
Cancer institute of Romagna
🇮🇹Forlì, Italy