Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours
A Phase III, Double-blind, Placebo-controlled, Randomised Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours
3 other identifiers
interventional
11,000
2 countries
82
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cancer
Started Oct 2015
Longer than P75 for phase_3 cancer
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 12, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
June 10, 2025
June 1, 2025
11 years
February 12, 2016
June 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Overall Survival
Overall survival of all cohorts combined
10 years follow up
Invasive disease-free survival (IDFS)
IDFS in the breast cancer cohort
6 years follow up
Disease-free survival (DFS)
DFS in the colorectal cancer cohort
6 years follow up
Overall survival
Overall survival in the gastro-oesophageal cancer cohort
5 years follow up
Biochemical recurrence-free survival (bRFS)
bRFS in the prostate cancer cohort
5 years follow up
Secondary Outcomes (5)
Adherence
5 years follow up
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
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
Study Arms (4)
Aspirin 100mg
ACTIVE COMPARATORAspirin 100mg
Placebo 100mg
PLACEBO COMPARATOR100mg Placebo
Aspirin 300mg
ACTIVE COMPARATORAspirin 300mg
Placebo 300mg
PLACEBO COMPARATOR300mg Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- WHO performance status 0, 1 or 2
- Participants should not be and have no intention of pregnancy or breast feeding during trial treatment
- Previous or current participants of other primary treatment trials if agreed in advance between trials
- No clinical or radiological evidence of residual or distant disease
- Men or women with histologically confirmed invasive breast cancer
- Undergone complete primary invasive tumour excision with clear margins
- Surgical staging of the axilla must have been undertaken by sentinel node biopsy, axillary sampling or dissection
- In those patients with a positive sentinel node biopsy:
- o If 1, 2 or 3 nodes are positive, subsequent management of the axilla (with surgery, radiotherapy or no further intervention) should be completed prior to registration
- o If 4 or more nodes are involved, patients must have undergone completion axillary node dissection
- Radiotherapy (RT)
- Patients who have undergone breastconserving surgery should have received adjuvant RT
- Patients who have undergone mastectomy should have received RT if they have more than 3 axillary lymph nodes involved
- Patients who have undergone mastectomy and have T3 tumours and/or 1, 2 or 3 involved lymph nodes may (or not) have received radiation per institutional practice
- +43 more criteria
You may not qualify if:
- Current or previous regular use of aspirin (at any dose) or current use of another NSAID for any indication.
- A past history of adverse reaction or hypersensitivity to NSAIDs, celecoxib, aspirin or other salicylates or sulphonamides, including asthma, that is exacerbated by use of NSAIDs.
- Current use of anticoagulants.
- Current or longterm use of oral corticosteroids. The treating physician should make the clinical decision whether a patient has been exposed to longterm therapy.
- Active or previous peptic ulceration
- Previous gastrointestinal bleeding except where the cause of the bleeding has been surgically removed.
- Active or previous history of inflammatory bowel disease.
- History of moderate or severe renal impairment, with eGFR\<45ml/min/1.73m2.
- Previous invasive or noninvasive malignancy except:
- \- DCIS where treatment consisted of resection alone. Prostate cancer initially treated with prostatectomy and now being treated with salvage radiotherapy following a rise in PSA.
- \- Cervical carcinoma in situ where treatment consisted of resection alone.
- Basal cell carcinoma where treatment consisted of resection alone or radiotherapy.
- Superficial bladder carcinoma where treatment consisted of resection alone.
- Other cancers where the patient has been diseasefree for ≥15 years.
- Any other physical condition which is associated with increased risk of aspirinrelated morbidity or, in the opinion of the Investigator, makes the patient unsuitable for the trial, including but not limited to severe asthma, haemophilia and other bleeding diatheses, macular degeneration and patients with a highrisk of mortality from another cause within the trial treatment period.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Bon Secours Hospital
Cork, Ireland
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
Mater Misericordiae University Hospital
Dublin, Ireland
Mater Private Hospital
Dublin, Ireland
St Luke's Hospital
Dublin, Ireland
St Vincent's Hospital
Dublin, Ireland
Tallaght University Hospital
Dublin, Ireland
University College Hospital Galway
Galway, Ireland
University Hospital Limerick
Limerick, Ireland
Sligo University Hospital
Sligo, Ireland
University Hospital Waterford
Waterford, Ireland
William Harvey Hospital
Ashford, United Kingdom
Stoke Mandeville Hospital
Aylesbury, United Kingdom
Ysbyty Gwynedd
Bangor, United Kingdom
North Devon District Hospital
Barnstaple, United Kingdom
Basildon Hospital
Basildon, United Kingdom
Bedford Hospital
Bedford, United Kingdom
Victoria Hospital
Blackpool, United Kingdom
Glan Clwyd Hospital
Bodelwyddan, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, United Kingdom
Fairfield Hospital
Bury, United Kingdom
West Suffolk Hospital
Bury St Edmunds, United Kingdom
Kent and Canterbury Hospital
Canterbury, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Velindre Hospital
Cardiff, United Kingdom
Cumberland Infirmary
Carlisle, United Kingdom
Cheltenham General Hospital
Cheltenham, United Kingdom
University Hospital Coventry and Warwickshire
Coventry, United Kingdom
Darlington Memorial Hospital
Darlington, United Kingdom
Darent Valley Hospital
Dartford, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
North Middlesex Hospital
Edmonton, United Kingdom
Royal Devon and Exeter Hospital
Exeter, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
The New Victoria Hospital
Glasgow, United Kingdom
Inverclyde Royal Hospital,
Greenock, United Kingdom
Princess Alexandra Hospital
Harlow, United Kingdom
Northwick Park Hospital
Harrow, United Kingdom
Wycombe Hospital
High Wycombe, United Kingdom
Hinchingbrooke Hospital
Huntingdon, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Airedale General Hospital
Keighley, United Kingdom
Kidderminster General Hospital
Kidderminster, United Kingdom
Kingston Hospital
Kingston, United Kingdom
Royal Lancaster Infirmary
Lancaster, United Kingdom
Lincoln County Hospital
Lincoln, United Kingdom
Royal Marsden Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
Luton & Dunstable Hospital
Luton, United Kingdom
Maidstone Hospital
Maidstone, United Kingdom
Christie Hospital
Manchester, United Kingdom
North Manchester General Hospital
Manchester, United Kingdom
Wythenshawe Hospital,
Manchester, United Kingdom
Queen Elizabeth The Queen Mother Hospital
Margate, United Kingdom
Milton Keynes University Hospital
Milton Keynes, United Kingdom
Friarage Hospital
Northallerton, United Kingdom
Northampton General Hospital
Northampton, United Kingdom
George Eliot Hospital
Nuneaton, United Kingdom
Royal Oldham Hospital
Oldham, United Kingdom
Royal Alexandra Hospital
Paisley, United Kingdom
Queen Alexandra Hospital
Portsmouth, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Alexandra Hospital
Redditch, United Kingdom
East Surrey Hospital
Redhill, United Kingdom
Queen's Hospital
Romford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
Lister Hospital
Stevenage, United Kingdom
Royal Marsden
Sutton, United Kingdom
King's Mill Hospital
Sutton in Ashfield, United Kingdom
Singleton Hospital
Swansea, United Kingdom
Great Western Hospital
Swindon, United Kingdom
Royal Cornwall Hospital
Truro, United Kingdom
Weston General Hospital
Weston-super-Mare, United Kingdom
West Cumberland Hospital
Whitehaven, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
Worcestershire Royal Hospital
Worcester, United Kingdom
Wrexham Maelor Hospital
Wrexham, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ruth Langley
MRC CTU at UCL
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2016
First Posted
June 17, 2016
Study Start
October 1, 2015
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
June 10, 2025
Record last verified: 2025-06