Non-Small Cell Lung Cancer Clinical Trial
Official title:
Low Molecular Weight Heparin in Advanced Non Small Cell Lung Cancer (NSCLC): a Randomized Open Label Phase III Study Evaluating the Effect of Enoxaparin (Clexane) on Survival and Symptom Control in Patients With Stage IIIB and IV NSCLC Undergoing a Cisplatin Based First Line Chemotherapy: the SYRINGES Trial
Rationale: a number of recent phase III randomized trials have shown a survival benefit of a
treatment with subcutaneous low-molecular weight heparin in patients with advanced solid
malignancies. The survival advantages observed in the studies persist for months after the
active treatment with LMWHs. Therefore these survival advantages are thought to be due to
effects of LMWHs on tumor cell biology.
First line treatment of advanced NSCLC patients with the Cisplatin + Docetaxel combination
has been widely studied, and is amongst the most active treatments currently available. The
occurrence of grade 3/4 thrombopenia in several phase III trials was in the 0-3% range,
making it an ideal chemotherapy regimen to combine with LMWHs in the treatment of advanced
NSCLC.
Purpose: the aim of this study is to evaluate the potential beneficial antitumoral effect of LMWH enoxaparin in patients with locally advanced or metastatic NSCLC determined by the time to progression, the overall survival and the symptom control. LMWH will be added to a first line cisplatin-based chemotherapy. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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