Evidence map›Paper›PMID 27777129›Full record

Trial reportContemporary clinical trials2016

ADD-ASPIRIN: 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.

Christopher Coyle, Fay H Cafferty, Samuel Rowley, Mairead MacKenzie, Lindy Berkman, Sudeep Gupta, C S Pramesh, Duncan Gilbert, Howard Kynaston, David Cameron and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Contemporary clinical trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 5 pooled it
17.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 5 syntheses or guidelines pooled it, 162 citations in OpenAlex.

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  20. The 125th Anniversary of Aspirin-The Story Continues.Pharmaceuticals (Basel, Switzerland) · 2024
    Review

33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 2 countries.

Christopher CoyleMRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.
Fay H CaffertyMRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.
Samuel RowleyMRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK.
Mairead MacKenzieIndependent Cancer Patient Voices, 17 Woodbridge Street, London EC1R 0LL, UK.
Lindy BerkmanNCRI Consumer Forum, Angel Building, 407 St John Street, London EC1V 4AD, UK.
Sudeep GuptaRoom No. 1109, 11th Floor, Homi Bhabha Block, Tata Memorial Centre/Hospital, Parel, Mumbai 400012, India.
C S PrameshDepartment of Surgical Oncology, Tata Memorial Centre, Dr Ernest Borges Marg, Parel, Mumbai 400012, India.
Duncan GilbertMRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK; Sussex Cancer Centre, Royal Sussex County Hospital, Eastern Road, Brighton, Sussex BN2 5BE, UK.
Howard KynastonRoom 2F65, Block A2, Cardiff School of Medicine, Heath Park, Cardiff CF14 4XN, UK.
David CameronEdinburgh Cancer Research Centre, University of Edinburgh, Western General Hospital, Crewe Road South, EH4 2XR, UK.
Richard H WilsonCentre for Cancer Research and Cell Biology, Queen's University Belfast, 97 Lisburn Road, Belfast BT9 7AE, Northern Ireland, UK.
Alistair RingThe Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT, UK.
Ruth E LangleyMRC Clinical Trials Unit, UCL, Aviation House, 125 Kingsway, London WC2B 6NH, UK. Electronic address: ruth.langley@ucl.ac.uk.
Add-Aspirin investigators
MRC Clinical Trials Unit at UCL · GBTata Memorial Hospital · INCardiff University · GBQueen's University Belfast · GBRoyal Marsden NHS Foundation Trust · GBRoyal Sussex County Hospital · GBWestern General Hospital · GB

Funding

Cancer Research UK 15015Cancer Research UK C471/A15015Department of Health 12/01/38Medical Research Council MC_UU_12023/28
6 · The paper itself

Abstract

backgroundThere is a considerable body of pre-clinical, epidemiological and randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy.

methodsAdd-Aspirin is a phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Patients who have undergone potentially curative treatment for breast (n=3100), colorectal (n=2600), gastro-oesophageal (n=2100) or prostate cancer (n=2120) are registered into four tumour specific cohorts. All cohorts recruit in the United Kingdom, with the breast and gastro-oesophageal cohort also recruiting in India. Eligible participants first undertake an active run-in period where 100mg aspirin is taken daily for approximately eight weeks. Participants who are able to adhere and tolerate aspirin then undergo a double-blind randomisation and are allocated in a 1:1:1 ratio to either 100mg aspirin, 300mg aspirin or a matched placebo to be taken daily for at least five years. Those participants ≥75years old are only randomised to 100mg aspirin or placebo due to increased toxicity risk.

resultsThe primary outcome measures are invasive disease-free survival for the breast cohort, disease-free survival for the colorectal cohort, overall survival for the gastro-oesophageal cohort, and biochemical recurrence-free survival for the prostate cohort, with a co-primary outcome of overall survival across all cohorts. Secondary outcomes include adherence, toxicity including serious haemorrhage, cardiovascular events and some cohort specific measures.

conclusionsThe Add-Aspirin trial investigates whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with four non-metastatic common solid tumours.

Indexed as

Survival RateAnti-Inflammatory Agents, Non-SteroidalAspirinBreast NeoplasmsChemotherapy, AdjuvantColorectal NeoplasmsDisease-Free SurvivalDouble-Blind MethodDrug HypersensitivityEsophageal NeoplasmsFemaleGastrointestinal HemorrhageHumansIndiaIntracranial HemorrhagesLongitudinal StudiesAnti-Inflammatory Agents, Non-SteroidalAspirinAspirinBreast cancerColorectal cancerGastro-oesophageal cancerProstate cancerRandomised controlled trial

Identifiers

PMID27777129
PMCPMC5127874
OpenAlexW2376159193

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.