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Ruth Langley research projects

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Medical Research Council Clinical Trials Unit
Aviation House
125 Kingsway
London
WC2B 6NH
United Kingdom

Email: rel@ctu.mrc.ac.uk
Tel: 020 7670 4718
Web: Lab website

CRUK/12/033: Add-Aspirin Trial- A phase III double-blind placebo-controlled randomized trial assessing the addition of aspirin after standard primary therapy in early stage common solid tumours

Funding period: 01 September 2013 to 31 August 2025
Funding scheme: Phase III Clinical Trial Grants
Funding committee: Clinical Trials Awards and Advisory Committee

Abstract

Background

Cancer is a global problem. There is a significant body of pre-clinical and epidemiological evidence demonstrating that aspirin has anti-cancer effects. Recently, individual patient data meta-analyses, from trials designed to assess cardiovascular benefits of aspirin, have shown reductions in cancer incidence and cancer mortality associated with regular aspirin use. Additionally, the CAPP2 trial has demonstrated that daily aspirin prevents cancers associated with the hereditary condition Lynch syndrome. 

In the meta-analyses, short-term effects on cancer mortality and a decrease in risk of metastases suggest a role for aspirin in the treatment as well as prevention of cancer. This is supported by several large observational datasets. Concerns over toxicity, particularly serious haemorrhage, have limited the use of aspirin in the primary prevention of cancer. In the adjuvant setting the benefit:risk ratio will be different, with higher morbidity and mortality from recurrent cancer potentially outweighing risks associated with regular aspirin use. 

Research into cancer treatments increasingly focuses on developing new, and usually expensive, agents and regimens, placing a growing strain on health services globally. Aspirin is a low-cost pharmaceutical that warrants further investigation as an anti-cancer agent in well-designed international studies. 

Aim

To assess whether regular aspirin use after standard therapy, including surgery and (neo-)adjuvant chemotherapy or radiotherapy, prevents recurrence and prolongs survival in patients with early stage common solid tumours. International recruitment will allow assessment of the intervention in different communities. 

Methods

The question will be addressed in four tumour sites (colorectal, breast, gastro-oesophageal, prostate) by means of parallel trials with a common infrastructure. Each trial will be a multicentre, phase III, double-blind, placebo-controlled randomized trial. 

Participants will have undergone potentially curative treatment, including any standard adjuvant therapy, and will be randomized to 100mg aspirin, 300mg aspirin or a matching placebo, to be taken daily for 5 years. 

Primary outcomes will depend on tumour site and trials will be separately powered, requiring 2000-3000 patients with each tumour type to demonstrate effects of aspirin on disease recurrence and survival. Secondary outcomes include overall survival, adherence, gastrointestinal complications and cardiovascular events. Translational work will investigate potential biomarkers of treatment response. 

How the results of this research will be used

Aspirin is an inexpensive, easily administered agent which is widely available. If it is shown to be beneficial as an adjuvant therapy, it could be implemented in both resource rich and resource poor countries and would have a huge impact, improving cancer outcomes worldwide.

Updated: 20 November 2013