The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service
研究概览
简要总结
Lung cancer is the most common cancer in the western world. Only 10 to 15 % of patients diagnosed with lung cancer are suitable for potentially curative surgical treatment. Despite surgery, recurrence of lung cancer still occurs. Aspirin potentially may help increase survival by altering the biochemistry of any potential remaining lung cancer cells. Most lung cancer occurs in smokers. Smokers are at increased risk of heart attacks and strokes. Aspirin has beneficial effects on the heart and brain, potentially reducing the incidence of heart attacks and strokes.
详细描述
Study design Randomised study of aspirin 75mg to reduce the mortality in patients after resection of non-small cell lung cancer. Patients already on aspirin, unsuitable for study or not wishing to partake in this study will be asked for permission to be followed up via their GP and the National Strategic Tracking service.
Methodology Initially all consultant thoracic and cardiothoracic surgeons in the UK will be consulted to obtain permission for their patients to be included in this study. If they agree the individual units' lung cancer nurses will actually be involved in recruiting post operative patients into the study. We will use the lung cancer nurses to enter via a secure electronic system patients pre operative characteristics and post operative staging and histology. Mortality will followed via the strategic tracing service.
Study subjects/patients All patients undergoing potentially curative resection of non small cell carcinoma of the lung. Patients will be recruited post operatively so that post operative deaths are eliminated, and histology is known prior to randomisation.
Contamination of control limb
Patients in the aspirin limb will be asked at their 1 year, 3 years and 5 years out patient appointment if they are still staking the aspirin. Patients in the control limb will be asked at their 1 year, 3 years and 5 years out patient appointment if they have been started on aspirin by anyone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 18 to 85, undergoing potentially curative resection of non small cell carcinoma of the lung, who have none of the following exclusion criteria.
排除标准
- •Already on aspirin Small cell carcinoma N2 disease Confirmed metastatic disease Incomplete resections Previous cancer in last 3 years History of gastric or duodenal ulcers Known allergy to aspirin or other NSAIDs.
研究组 & 干预措施
Positive control
Already on aspirin. just observational limb
干预措施: Aspirin 75 mg (Drug)
Negative control
Not on aspirin pre operatively, but refuse to enter trial or have a contraindication to aspirin
干预措施: no aspirin (Other)
Aspirin treatment
group randomised to aspirin
干预措施: Aspirin 75 mg (Drug)
No aspirin treatment
Randomised to no aspirin
干预措施: no aspirin (Other)
结局指标
主要结局
Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service
时间窗: 5 years
次要结局
- Side effects eg gastrointestinal(5 years)