Multicenter, Randomized, Open and Sequential Study to Evaluate the Efficacy and Safety of Bemiparin Administration on the Response to Treatment in Patients Diagnosed With Limited Small Cell Lung Cancer
There is clinical evidence indicative of the beneficial effects of heparin in the evolution
of patients with cancer. Apart from the studies that in an indirect way demonstrated an
increase in the survival of oncological patients who, because of presenting a venous
thromboembolism episode, were treated with low molecular weight heparin (LMWH) in comparison
with those treated with non-fractionated heparin; direct actions were also demonstrated from
the use of heparin in the survival and tumour progression. The administration of LMWH
together with Chemotherapy has been proved to increase the survival of patients diagnosed of
cancer of the pancreas in relation to those only treated with chemotherapy. An increase in
the global survival of advanced solid tumours, with no thromboembolic disease,has also been
showed.
All this suggests that an improvement in the survival of patients is observed when heparin
is added to the usual anti-tumour treatment, especially to those without spread disease, and
this effect seems to be independent of the protection against the thromboembolic
complications.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
efficacy: progression-free survival in months (measurements of the size of the effect will be done using the Kaplan Meier method and the difference between the means of this time)
efficacy
No
Alfonso Gúrpide, MD
Principal Investigator
Clínica Universitaria de Navarra
Spain: Spanish Agency of Medicines
ICT-BEM-2004-01
NCT00324558
June 2005
September 2010
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