A randomised phase III clinical trial investigating the effect of Fragmin® added to standard therapy In patients with lung cancer
| ISRCTN | ISRCTN80812769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80812769 |
| ClinicalTrials.gov (NCT) | NCT00519805 |
| Clinical Trials Information System (CTIS) | 2005-002438-37 |
| Protocol serial number | 2005-002438-37 |
| Sponsor | Velindre NHS Trust (UK) |
| Funders | Cancer Research UK, Pfizer UK |
- Submission date
- 24/05/2005
- Registration date
- 08/07/2005
- Last edited
- 26/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Fergus Macbeth
Scientific
Scientific
NICE
Holborn
London
WC1V 6NA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised phase III clinical trial investigating the effect of FRAGMin® Added to standard Therapy In patients with lung Cancer |
| Study acronym | FRAGMATIC |
| Study objectives | To assess the effect of adding six months of daily dalteparin (Fragmin) to standard treatment for patients with lung cancer. |
| Ethics approval(s) | MREC for Wales, 08/08/2006, ref: 06/MRE09/29 |
| Health condition(s) or problem(s) studied | Lung cancer |
| Intervention | The trial is a multicentre randomised phase III trial. Patients are randomised to one of two groups with a 1:1 randomisation: 1. Control group: to receive anti-cancer treatment according to local practice 2. Intervention group: to receive anti-cancer treatment according to local practice plus once daily sub-cutaneous dalteparin (fragmin) for six months at a thromboprophylactic dose |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Dalteparin (fragmin) |
| Primary outcome measure(s) |
Overall survival |
| Key secondary outcome measure(s) |
1. Venous thrombotic event (VTE) free survival |
| Completion date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 2200 |
| Total final enrolment | 2202 |
| Key inclusion criteria | Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology. |
| Key exclusion criteria | 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. Known cerebral metastases 4. Haemoptysis of CTC Grade two (symptomatic haemoptysis requiring medical intervention) or above 5. Known bleeding diathesis 6. Known pregnancy or lactation 7. Known allergy to heparin 8. Platelet count lower than 100 x 10^9/l 9. Renal impairment with serum creatinine greater than 150 µmol/l 10. Patients who have received therapeutic anticoagulation in the last 12 months 11. Patients taking Ketorolac |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 31/10/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NICE
London
WC1V 6NA
United Kingdom
WC1V 6NA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/02/2016 | Yes | No | |
| Results article | results | 20/07/2016 | Yes | No | |
| Protocol article | protocol | 06/10/2009 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 26/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
19/03/2020: EudraCT number added. Added EudraCT link to basic results (scientific).
23/02/2018: Publication reference added.
10/06/2016: Publication reference added.
15/02/2011: the overall trial end date was changed from 31/12/2010 to 31/10/2011.
