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

INTERVENTION: Product Name: docetaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: docetaxel CAS Number: 114977‐28‐5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40‐ Product Name: cisplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 15663271 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1‐ Product Name: enoxaparin Pharmaceutical Form: Solution for injection INN or Proposed INN: enoxaparin sodium CAS Number: 9041081 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100‐ CONDITION: Non Small Cell Lung Cancer ; MedDRA version: 9.1 Level: LLT Classification code 10025054 Term: Lung cancer non‐small cell stage IIIB ; MedDRA version: 9.1 Level: LLT Classification code 10025055 Term: Lung cancer non‐small cell stage IV PRIMARY OUTCOME: Main Objective: The aim of this study is to determine the potential beneficial antitumoral effect of enoxaparin in patients with advanced NSCLC treated with cisplatin‐based chemotherapy. ; Primary endpoint: Progression Free Survival (PFS); Primary end point(s): Progression Free Survival (PFS) Secondary Objective: Main secondary objective: Symptom control evaluated with the Lung Cancer Symptoms Scale (LCSS) ; Other secondary objectives: ; ‐Overall Survival (OS); ‐Best Overall Response (OR); ‐Incidence of total documented thromboembolic and hemorrhagic events; ‐Overall safety and tolerability; INCLUSION CRITERIA: ‐Locally advanced or metastatic NSCLC (stage IIIB‐IV) ‐patients who are not candidates for radical combined modality treatments or high‐dose radiation therapy ‐At least one measurable lesion according to RECIST criteria ‐Good performance status (KPS 100‐70) ‐Age =18 years. ‐Adequate haematological, renal and liver function ‐Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range