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

  • STATUS
    Recruiting
  • End date
    Oct 2, 2026
  • participants needed
    11000
  • sponsor
    University College, London
Updated on 2 March 2021
aspirin
prostatectomy
systemic therapy
carcinoma
breast cancer
endocrine therapy
metastasis
hormone therapy
liver metastasis
HER2
trastuzumab
cancer treatment
primary cancer
adenocarcinoma
erbb2
invasive breast cancer
mastectomy
adjuvant chemotherapy
immunostimulant
sentinel node
sentinel lymph node biopsy
immunostimulants
adenocarcinoma of colon
immunological adjuvant

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.

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.

Details
Condition Malignant neoplasm of prostate, Prostate Cancer, Prostate Cancer, Early, Recurrent, Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal disorder, Rectal Disorders, Cancer, Cancer/Tumors, Neoplasms, Cancer (Pediatric), Ewing's Family Tumors, Cancer, Prostatic disorder, Prostate Disorders, Breast Cancer, Breast Cancer, Prostate Disorders, Colon Cancer Screening, Cancer/Tumors, Prostate Cancer, Early, Recurrent, Rectal Disorders, Colon cancer; rectal cancer, Breast Cancer Diagnosis, Ewing's Family Tumors, Gastro-oesophageal Cancer, Cancer (Pediatric), Prostate Cancer, Neoplasms, breast carcinoma, colorectal neoplasm, prostate carcinoma, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, cancer, breast, colorectal cancers, prostate cancers, cancer, colorectal, colorectal tumor, tumors, colorectal, Gastro-oesophageal Cancer, Gastro-oesophageal Cancer, Gastro-oesophageal Cancer
Treatment Aspirin 100mg, Aspirin 300mg, Placebo 100mg, Placebo 300mg
Clinical Study IdentifierNCT02804815
SponsorUniversity College, London
Last Modified on2 March 2021

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