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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,166
Nadroparin calcium; Pre-filled syringes of 0.4 ml (3.800 anti-Xa IU), 1 subcutaneous injection/day (every 24 hours).
Pre-filled syringes of 0.4 ml , 1 subcutaneous injection/day (every 24 hours).
Medical Oncology Department
Fabriano, Ancona, Italy
Medical Oncology Department Oncology Institute
Bari, Bari, Italy
Medical Oncology Unit
Bergamo, Bergamo, Italy
Medical Oncology Department
Treviglio, Bergamo, Italy
Medical Oncology Department - Bellaria Hospital
Bologna, Bologna, Italy
Cumulative incidence of symptomatic venous and arterial thromboembolism, in patients with metastatic or locally advanced solid tumors undergoing chemotherapy
Time frame: Events occurring during the four months of treatment plus 10 days
Survival, at the end of study treatment
Time frame: Events occurring during the four months of treatment plus 10 days
Response to chemotherapy
Time frame: 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
Time frame: Events occurring during the four months of treatment plus 10 days
Superficial thrombophlebitis of lower limbs
Time frame: Events occurring during the four months of treatment plus 10 days
Asymptomatic thromboembolic events diagnosed during tests performed for other purposes
Time frame: Events occurring during the four months of treatment plus 10 days
Safety (major bleeding, minor bleeding, other adverse events)
Time frame: Events occurring during the four months of treatment plus 48 hours
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Medical Oncology Department - Businco Hospital
Cagliari, Cagliari, Italy
Medical Oncology Department University of Cagliari
Cagliari, Cagliari, Italy
Medical Oncology Department
Catanzaro, Catanzaro, Italy
Medical Oncology Department
Cosenza, Cosenza, Italy
Medical Oncology Department
Cremona, Cremona, Italy
...and 36 more locations