The aim of this trial, which is called FRAGMATIC, is to assess the effect of adding a blood thinning drug called dalteparin (FRAGMIN®) for 24 weeks to standard treatment for patients with lung cancer to see if if has any affect on survival.
- Conditions
- ung cancerMedDRA version: 14.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-002438-37-GB
- Lead Sponsor
- Velindre NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 2202
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
F.1.3.1 Number of subjects for this age range 200
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.
11. Patients who have received therapeutic anticoagulation in the last 12 months.
12. Patients taking Ketorolac (toradol) - this is a non steroidal anti-inflammatory drug (NSAID) with a well documented risk of causing increased bleeding when given with LMWH
13. Patients who at the time of randomisation have a central venous catheter in place and the local practice specifies the use of thromboprophylaxis
14. Any other active malignancy in the last 5 years, except completely treated non-melanoma skin cancer or in-situ carcinoma of cervix. Patients with previous malignancies in remission for at least 5 years can be included, provided that there is a clear MDT decision that this is a new primary.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of adding 24 weeks of daily dalteparin (Fragmin) to standard treatment for patients with lung cancer in terms of overall survival. Assessed using an open randomised trial.;<br> Secondary Objective: Venous thrombotic event (VTE) free survival<br> Serious adverse events (SAEs)<br> Metastasis-free survival<br> Toxicity<br> Quality of life<br> Levels of breathlessness<br> Anxiety and depression<br> Cost effectiveness<br> Cost utility<br> ;Primary end point(s): Overall survival.;Timepoint(s) of evaluation of this end point: At the end of the trial and follow up period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): analysis of VTE free survival and matastasis free survival;Timepoint(s) of evaluation of this end point: at the end of the trial and after the follow up period