Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours
- Conditions
- Breast CancerColorectal CancerCancerProstate CancerGastro-oesophageal Cancer
- Interventions
- Registration Number
- NCT02804815
- Lead Sponsor
- University College, London
- Brief Summary
Add-Aspirin aims to assess whether regular aspirin use after standard curative therapy can prevent recurrence and improve survival in individuals with non-metastatic common tumours. The question will be assessed in four different tumour types (breast, colorectal, gastro-oesophageal and prostate) by means of parallel cohorts within an overarching trial protocol.
Eligible participants will be randomly assigned (double-blind) to either aspirin 100mg, aspirin 300mg or a matched placebo, to be taken daily for at least 5 years. Disease recurrence and survival will be assessed, along with adherence, toxicity, and other potential effects of aspirin (eg. cardiovascular).
There is a large body of evidence indicating that aspirin has anti-cancer effects. Meta-analyses of cardiovascular trials of aspirin have shown short-term effects on cancer mortality and a decrease in risk of metastases, suggesting a role for aspirin in the treatment as well as prevention of cancer. Additionally, large observational studies of individuals taking aspirin after cancer treatment have shown improved disease-specific and overall mortality for specific tumour types.
In the treatment setting, the risks of side effects associated with aspirin are expected to be outweighed by potential benefits. However, this has not yet been assessed in a randomised trial.
As a low cost, generic and widely available drug, which is generally safe, if aspirin is shown to be effective, it could have a huge impact on cancer outcomes globally.
- Detailed Description
A phase III, multi-centre, double-blind, placebo-controlled randomised trial which aims to assess whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with non-metastatic common solid tumours.
The trial has four parallel tumour site-specific cohorts (breast, colorectal, gastro-oesophageal and prostate cancer). An overarching protocol ensures each cohort is as comparable as possible to allow a combined analysis of overall survival as a co-primary outcome measure in addition to individual tumour site-specific analyses of disease recurrence and survival.
Participants who have undergone potentially curative treatment (surgery or other radical treatment), including any standard neo-adjuvant or adjuvant therapy for breast, colorectal, gastro-oesophageal or prostate cancer or have participated in any pre-approved trials and satisfy the eligibility criteria.
Participants will be randomly assigned to 100mg aspirin, 300mg aspirin or matched placebo. All tablets will be enteric-coated to be taken daily for at least five years. Prior to randomisation, all potential participants will take open-label 100mg aspirin daily for a run-in period of approximately 8 weeks to assess tolerability and adherence.
The trial incorporates a feasibility phase during which recruitment feasibility, treatment adherence, safety and use of the run-in period will be assessed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 11000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Aspirin 300mg Aspirin 300mg Aspirin 300mg Placebo 300mg Placebo 300mg 300mg Placebo Placebo 100mg Placebo 100mg 100mg Placebo Aspirin 100mg Aspirin 100mg Aspirin 100mg
- Primary Outcome Measures
Name Time Method Overall Survival 10 years follow up Overall survival of all cohorts combined
Biochemical recurrence-free survival (bRFS) 5 years follow up bRFS in the prostate cancer cohort
Disease-free survival (DFS) 6 years follow up DFS in the colorectal cancer cohort
Invasive disease-free survival (IDFS) 6 years follow up IDFS in the breast cancer cohort
Overall survival 5 years follow up Overall survival in the gastro-oesophageal cancer cohort
- Secondary Outcome Measures
Name Time Method Number of participants with second malignancies as assessed by case report form 5 years follow up Number of participants that show a decline in cognition and extent of decline as assessed by the Montreal Cognitive Assessment (MoCA) 5 years follow up Adherence 5 years follow up Patient-reported compliance (via diary card) will be assessed during the run-in period
Number of participants with serious haemorrhage (grade 3 or above) as measured by CTCAE V4.0. Data will be collected on case report forms. 5 years follow up Number of participants with treatment-related (active drug and placebo) cardiovascular events as assessed by CTCAE v4.0 5 years follow up
Trial Locations
- Locations (82)
Christie Hospital
🇬🇧Manchester, United Kingdom
Bon Secours Hospital
🇮🇪Cork, Ireland
Mater Misericordiae University Hospital
🇮🇪Dublin, Ireland
Mater Private Hospital
🇮🇪Dublin, Ireland
St Luke's Hospital
🇮🇪Dublin, Ireland
St Vincent's Hospital
🇮🇪Dublin, Ireland
University College Hospital Galway
🇮🇪Galway, Ireland
University Hospital Limerick
🇮🇪Limerick, Ireland
Sligo University Hospital
🇮🇪Sligo, Ireland
University Hospital Waterford
🇮🇪Waterford, Ireland
Bedford Hospital
🇬🇧Bedford, United Kingdom
Bristol Haematology & Oncology Centre
🇬🇧Bristol, United Kingdom
West Suffolk Hospital
🇬🇧Bury St Edmunds, United Kingdom
Fairfield Hospital
🇬🇧Bury, United Kingdom
Velindre Hospital
🇬🇧Cardiff, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, United Kingdom
The New Victoria Hospital
🇬🇧Glasgow, United Kingdom
Hinchingbrooke Hospital
🇬🇧Huntingdon, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, United Kingdom
Luton & Dunstable Hospital
🇬🇧Luton, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
East Surrey Hospital
🇬🇧Redhill, United Kingdom
Queen's Hospital
🇬🇧Romford, United Kingdom
Weston Park Hospital
🇬🇧Sheffield, United Kingdom
Lister Hospital
🇬🇧Stevenage, United Kingdom
Royal Marsden
🇬🇧Sutton, United Kingdom
Basildon Hospital
🇬🇧Basildon, United Kingdom
William Harvey Hospital
🇬🇧Ashford, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Beaumont Hospital
🇮🇪Dublin, Ireland
Stoke Mandeville Hospital
🇬🇧Aylesbury, United Kingdom
Victoria Hospital
🇬🇧Blackpool, United Kingdom
Pilgrim Hospital
🇬🇧Boston, United Kingdom
Tallaght University Hospital
🇮🇪Dublin, Ireland
Ysbyty Gwynedd
🇬🇧Bangor, United Kingdom
Kidderminster General Hospital
🇬🇧Kidderminster, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
Alexandra Hospital
🇬🇧Redditch, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Royal Albert Edward Infirmary
🇬🇧Wigan, United Kingdom
Glan Clwyd Hospital
🇬🇧Bodelwyddan, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
University Hospital Coventry and Warwickshire
🇬🇧Coventry, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Cheltenham General Hospital
🇬🇧Cheltenham, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
Darent Valley Hospital
🇬🇧Dartford, United Kingdom
North Middlesex Hospital
🇬🇧Edmonton, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Princess Alexandra Hospital
🇬🇧Harlow, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, United Kingdom
Inverclyde Royal Hospital,
🇬🇧Greenock, United Kingdom
Wycombe Hospital
🇬🇧High Wycombe, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
Kingston Hospital
🇬🇧Kingston, United Kingdom
Airedale General Hospital
🇬🇧Keighley, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
Royal Marsden Hospital
🇬🇧London, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
Queen Elizabeth The Queen Mother Hospital
🇬🇧Margate, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, United Kingdom
Friarage Hospital
🇬🇧Northallerton, United Kingdom
Wythenshawe Hospital,
🇬🇧Manchester, United Kingdom
Milton Keynes University Hospital
🇬🇧Milton Keynes, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
George Eliot Hospital
🇬🇧Nuneaton, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom
King's Mill Hospital
🇬🇧Sutton-in-Ashfield, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Weston General Hospital
🇬🇧Weston Super Mare, United Kingdom
West Cumberland Hospital
🇬🇧Whitehaven, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, United Kingdom
Cork University Hospital
🇮🇪Cork, Ireland