Condition category
Cancer
Date applied
24/05/2005
Date assigned
08/07/2005
Last edited
10/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Fergus Macbeth

ORCID ID

Contact details

NICE
Holborn
London
WC1V 6NA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00519805

Protocol/serial number

2005-002438-37

Study information

Scientific title

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

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

MREC for Wales, 08/08/2006, ref: 06/MRE09/29

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Phase III

Drug names

Dalteparin (fragmin)

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

31/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with histopathologically or cytologically confirmed primary lung cancer of any stage or histology.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2200

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

United Kingdom

Trial participating centre

NICE
London
WC1V 6NA
United Kingdom

Sponsor information

Organisation

Velindre NHS Trust (UK)

Sponsor details

Unit 2
Charnwood Court
Parc Nantgarw
Cardiff
CF15 7QW
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Industry

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Pfizer UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19807917
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26700124

Publication citations

  1. Protocol

    Griffiths GO, Burns S, Noble SI, Macbeth FR, Cohen D, Maughan TS, FRAGMATIC: a randomised phase III clinical trial investigating the effect of fragmin added to standard therapy in patients with lung cancer., BMC Cancer, 2009, 9, 355, doi: 10.1186/1471-2407-9-355.

  2. Results

    Macbeth F, Noble S, Evans J, Ahmed S, Cohen D, Hood K, Knoyle D, Linnane S, Longo M, Moore B, Woll PJ, Appel W, Dickson J, Ferry D, Brammer C, Griffiths G, Randomized Phase III Trial of Standard Therapy Plus Low Molecular Weight Heparin in Patients With Lung Cancer: FRAGMATIC Trial, J Clin Oncol, 2016 , 34, 5, 488-494, doi: 10.1200/JCO.2015.64.0268.

Additional files

Editorial Notes

10/06/2016: Publication reference added. 15/02/2011: the overall trial end date was changed from 31/12/2010 to 31/10/2011.