A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer - FRAGMATIC

Velindre NHS Trust0 sites2,202 target enrollmentNovember 22, 2006

Overview

No summary available.

Registry

who.int

Start Date

November 22, 2006

End Date

August 22, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Velindre NHS Trust

•1\. Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non\-small cell) within the last 7 weeks.
•2\. Age 18 or over.
•3\. ECOG Performance status 0, 1, 2 or 3\.
•4\. Willing and able to self\-administer LMWH by daily sub\-cutaneous injection or have it administered to them by a carer.
•5\. Willing and able to give 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 2000
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Patients with other intrathoracic tumours (e.g. carcinoid, mesothelioma, lymphoma, lung metastases from another primary site).
•2\. Any previous illness or treatment likely to interfere with protocol treatment or comparisons.
•3\. Clinically apparent brain metastases.
•4\. Patients who have had a haemorrhagic stroke in the last 3 months
•5\. Haemoptysis of CTC Grade 2 (symptomatic haemoptysis requiring medical intervention) or above.
•6\. Known bleeding disorder.
•7\. Known pregnancy or lactation. Effective contraception is essential for all female patients (of reproductive potential) if sexually active.
•8\. Known hypersensitivity to dalteparin or other low molecular weight heparins and/or heparins (eg history of confirmed or suspected immunologically mediated heparin induced thrombocytopenia; acute gastroduodenal ulcer; subacute endocarditis)
•9\. Platelet count lower than 100 x 10 9/L.
•10\. Renal impairment with serum creatinine greater than 150 mol/L.