ow 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 - SYRINGES

Phase 1

Conditions: on Small Cell Lung Cancer
MedDRA version: 9.1Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIB
MedDRA version: 9.1Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IV

Registration Number: EUCTR2007-007696-16-BE

Lead Sponsor: TOGA Thoracic Oncology Group Antwerp

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

Exclusion Criteria

-Previous chemotherapy for NSCLC
-Brain metastasis
-history of cerebral haemorrhage, neurosurgery within 3 previous months or Surgery within the past 6 weeks
-Indication for anticoagulant therapy or thrombolytic therapy
-Concomitant therapy with an anti-angiogenesis agent
-Contra-indication for LMWH
-Life expectancy of <3 months.
-Serious concomitant systemic disease, uncontrolled arterial hypertension, Active peptic ulcer or other condition which do not permit study treatment or follow up required to comply with the study protocol