Status:
COMPLETED
Enoxaparin Low Molecular Weight Heparin (LMWH) in Advanced Non Small Cell Lung Cancer: Effect on Survival and Symptom Control in Patients Undergoing First Line Chemotherapy (SYRINGES)
Lead Sponsor:
University Hospital, Antwerp
Collaborating Sponsors:
Universiteit Antwerpen
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Locally advanced or metastatic NSCLC (stage IIIB or 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
- Adequate haematological, renal and liver function
- Written informed consent
Exclusion
- Previous chemotherapy for NSCLC
- Brain metastasis
- History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months
- Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease
- 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 does not permit study treatment or follow-up required to comply with the study protocol
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00771563
Start Date
June 1 2008
End Date
October 1 2012
Last Update
June 28 2013
Active Locations (2)
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1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
2
Centre Hospitalier Universitaire Sart Tilman
Liège, Liège, Belgium, 4000