Abstract
BackgroundVenous thromboembolism (VTE) occurs when blood clots in the leg, pelvic or other deep vein (deep vein thrombosis) with or without transport of the thrombus into the pulmonary arterial circulation (pulmonary embolus). VTE is common in patients with cancer and is increased by surgery, chemotherapy, radiotherapy and disease progression. Low molecular weight heparin (LMWH) is routinely used to treat VTE and some evidence suggests that LMWH may also have an anticancer effect, by reduction in the incidence of metastases. The FRAGMATIC trial will assess the effect of adding dalteparin (FRAGMIN), a type of LMWH, to standard treatment for patients with lung cancer.Methods/DesignThe study design is a randomised multicentre phase III trial comparing standard treatment and standard treatment plus daily LMWH for 24 weeks in patients with lung cancer. Patients eligible for this study must have histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell) within 6 weeks of randomisation, be 18 or older, and must be willing and able to self-administer 5000 IU dalteparin by daily subcutaneous injection or have it administered to themselves or by a carer for 24 weeks. A total of 2200 patients will be recruited from all over the UK over a 3 year period and followed up for a minimum of 1 year after randomisation. Patients will be randomised to one of the two treatment groups in a 1:1 ratio, standard treatment or standard treatment plus dalteparin. The primary outcome measure of the trial is overall survival. The secondary outcome measures include venous thrombotic event (VTE) free survival, serious adverse events (SAEs), metastasis-free survival, toxicity, quality of life (QoL), levels of breathlessness, anxiety and depression, cost effectiveness and cost utility.Trial registrationCurrent Controlled Trials ISRCTN80812769
Highlights
Venous thromboembolism (VTE) occurs when blood clots in the leg, pelvic or other deep vein with or without transport of the thrombus into the pulmonary arterial circulation
Venous thromboembolism (VTE) is common in patients with any cancer and the incidence is increased by surgery, chemotherapy, radiotherapy and disease progression [58]
In the 629 cancer patients treated (306 Low molecular weight heparin (LMWH) vs 323 unfractionated heparin (UFH)), the pooled odds ratio for 3 month mortality was 0.61 (95% confidence interval 0.4-0.93) in favour of LMWH. In these studies a wide variety of cancer subtypes were present. While this trial did not control for important cancer prognostic variables, such as tumour type and standard treatment, it provided an impetus for researchers to continue investigating heparin's potential as an antineoplastic agent
Summary
Lung cancer and thromboembolism In the UK about 33,000 patients are diagnosed with lung cancer every year, with a median 1-year survival of 20% [1]. In these studies a wide variety of cancer subtypes were present While this trial did not control for important cancer prognostic variables, such as tumour type and standard treatment, it provided an impetus for researchers to continue investigating heparin's potential as an antineoplastic agent. Choice of heparin and dose in the trial Dalteparin is a low molecular weight heparin with antithrombotic properties demonstrated by enhancing the inhibition of Factor Xa and thrombin, by anti-thrombin It potentiates preferentially, the inhibition of coagulation Factor Xa, while only slightly affecting activated partial thromboplastin time (APTT). Main research question The main study aim of the FRAGMATIC trial is to assess the effect on overall survival of adding Low Molecular Weight Heparin, dalteparin (FRAGMIN®) for 24 weeks to standard treatment for patients with lung cancer.
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