Clinical trial NCT01058902: The Effect Of Aspirin On Survival in Lung Cancer
Official title: The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Non Small Cell Lung Cancer
Survival
Aspirin
Keywords: Non small cell lung cancer
survival
aspirin
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

If these appointments are missed the patients GP will be contacted for this information, as long as the patient has agreed for us to contact their GP.

Data collection This will be prospective via a secure web server, hosted on an NHS computer located in a secure NHS IT locked room.

Study procedures No invasive procedure, samples or tissues will be performed or obtained in any patients.

Study intervention Aspirin 75 mg/day or no tablet taken for a period of 5 years after randomisation.

Reducing adverse events

All patients will be assessed by the researcher to eliminated patients with as history of gastric or duodenal ulcers, or known allergy to aspirin or other NSAIDs.

Monitoring of Adverse events All patients will be given a business card with a contact number, an email address and a web address so that they can report all adverse events while participating in this trial. In addition all general practitioners with patients in the trial will be notified.

Specific adverse events we will be following include:

Stopping trial medication secondary to side effects, GI bleeds, stomach ulcers, anaemia that require hospital admission and Blood transfusion(s)

Data Monitoring Committee The data management committee will analyse survival data in the control and intervention limb every 6 months up to 5 years with regard to mortality and gastrointestinal side effects that required hospital admission.

If the mortality in the aspirin treatment group exceeds more than 3 Standard deviations above the control mortality rate the trial will be stopped immediately and the aspirin users all contacted immediately and informed to stop the aspirin immediately.

The gastrointestinal side effects of aspirin have been widely studied and as aspirin is an over the counter product being used in its lowest dose formulation we do not aim to use gastrointestinal side effects as a marker for stopping the trial.

GP contacts All GPs will be informed of their patients inclusion in this trial.

Statistical analysis. This will be performed by Dr Mark Jackson or a delegated member of his team, at Liverpool Heart and Chest Hospital.

Sample size Based on a retrospective trail conducted in Liverpool Heart and Chest hospital. Accepting the suggested hazard ratio of 0.84 and a difference in 5-year survival of approximately 6%, various power calculations were performed to derive an estimate of the sample size required for such a trial. Depending on the aspirin:non-aspirin ratio and based on standard assumptions, a combined total of between 2000 and 3000 patients would need to be recruited to detect a significant difference in survival. Hence we aim to recruit 2,500 patients.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service
timeFrame: 5 years
Secondary outcomes:
measure: Side effects eg gastrointestinal
timeFrame: 5 years
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
state: Merseyside
Study officials:
affiliation: Liverpool Heart and Chest Hospital
name: Mike Mr Poullis, FRCS(CTh)
role: PRINCIPAL_INVESTIGATOR
References: