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 |
| EudraCT/CTIS number | 2005-002438-37 |
| ClinicalTrials.gov number | NCT00519805 |
| Secondary identifying numbers | 2005-002438-37 |
- 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
Contact information
Dr Fergus Macbeth
Scientific
Scientific
NICE
Holborn
London
WC1V 6NA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a 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 hypothesis | 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 |
| Condition | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Dalteparin (fragmin) |
| Primary outcome measure | Overall survival |
| Secondary outcome measures | 1. Venous thrombotic event (VTE) free survival 2. Serious Adverse Events (SAEs) 3. Metastasis-free survival 4. Toxicity 5. Quality of life 6. Levels of breathlessness 7. Anxiety and depression 8. Cost effectiveness and cost utility |
| Overall study start date | 01/01/2006 |
| Overall study end date | 31/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2200 |
| Total final enrolment | 2202 |
| Participant inclusion criteria | Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology. |
| Participant 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 |
| Recruitment start date | 01/01/2006 |
| Recruitment end date | 31/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NICE
London
WC1V 6NA
United Kingdom
WC1V 6NA
United Kingdom
Sponsor information
Velindre NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Unit 2, Charnwood Court
Parc Nantgarw
Cardiff
CF15 7QW
Wales
United Kingdom
"ROR" |
https://ror.org/05ntqkc30 |
|---|
Funders
Funder type
Industry
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CRUK
- Location
- United Kingdom
Pfizer UK
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Ltd
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Protocol article | protocol | 06/10/2009 | Yes | No | |
| Results article | results | 10/02/2016 | Yes | No | |
| Results article | results | 20/07/2016 | Yes | No | |
| 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.
