Add-Aspirin: A Trial Assessing the Effects of Aspirin on Disease Recurrence and Survival After Primary Therapy in Common Non Metastatic Solid Tumours
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|ClinicalTrials.gov Identifier: NCT02804815|
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : November 22, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Breast Cancer Prostate Cancer Colorectal Cancer Gastro-oesophageal Cancer||Drug: Aspirin 100mg Drug: Aspirin 300mg Drug: Placebo 100mg Drug: Placebo 300mg||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||11000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||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|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||October 2026|
Active Comparator: Aspirin 100mg
Drug: Aspirin 100mg
Placebo Comparator: Placebo 100mg
Drug: Placebo 100mg
Active Comparator: Aspirin 300mg
Drug: Aspirin 300mg
Placebo Comparator: Placebo 300mg
Drug: Placebo 300mg
- Overall Survival [ Time Frame: 10 years follow up ]Overall survival of all cohorts combined
- Invasive disease-free survival (IDFS) [ Time Frame: 6 years follow up ]IDFS in the breast cancer cohort
- Disease-free survival (DFS) [ Time Frame: 6 years follow up ]DFS in the colorectal cancer cohort
- Overall survival [ Time Frame: 5 years follow up ]Overall survival in the gastro-oesophageal cancer cohort
- Biochemical recurrence-free survival (bRFS) [ Time Frame: 5 years follow up ]bRFS in the prostate cancer cohort
- Adherence [ Time Frame: 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. [ Time Frame: 5 years follow up ]
- Number of participants with treatment-related (active drug and placebo) cardiovascular events as assessed by CTCAE v4.0 [ Time Frame: 5 years follow up ]
- Number of participants with second malignancies as assessed by case report form [ Time Frame: 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) [ Time Frame: 5 years follow up ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804815
|Contact: Gemma Sanchafirstname.lastname@example.org|
|Contact: Alex Robbinsemail@example.com|
|Study Director:||Ruth Langley||MRC CTU at UCL|