Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours

Phase 3

Active, not recruiting

• Conditions: Breast Cancer; Colorectal Cancer; Cancer; Prostate Cancer; Gastro-oesophageal Cancer
• Interventions: Drug: Aspirin 300mg; Drug: Placebo 300mg; Drug: Placebo 100mg; Drug: Aspirin 100mg

• 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 11000

Inclusion Criteria

Not provided

Exclusion Criteria

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 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
Number of participants with second malignancies as assessed by case report form	5 years follow up

Trial Locations

Locations (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

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