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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 11,000
- 试验地点
- 82
- 主要终点
- Overall Survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo 300mg
300mg Placebo
干预措施: Placebo 300mg (Drug)
Aspirin 100mg
Aspirin 100mg
干预措施: Aspirin 100mg (Drug)
Placebo 100mg
100mg Placebo
干预措施: Placebo 100mg (Drug)
Aspirin 300mg
Aspirin 300mg
干预措施: Aspirin 300mg (Drug)
结局指标
主要结局
Overall Survival
时间窗: 10 years follow up
Overall survival of all cohorts combined
Biochemical recurrence-free survival (bRFS)
时间窗: 5 years follow up
bRFS in the prostate cancer cohort
Disease-free survival (DFS)
时间窗: 6 years follow up
DFS in the colorectal cancer cohort
Invasive disease-free survival (IDFS)
时间窗: 6 years follow up
IDFS in the breast cancer cohort
Overall survival
时间窗: 5 years follow up
Overall survival in the gastro-oesophageal cancer cohort
次要结局
- 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)
- 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)