Non Small Cell Lung CancerPhase 3NCT01058902
The Effect Of Aspirin On Survival in Lung Cancer
A Phase 3 study testing Aspirin 75 mg and no aspirin in people with Non Small Cell Lung Cancer and Survival, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Survival, Aspirin
- What is being tested?
- Aspirin 75 mg and no aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Aug 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, L14 3PE
About this study
Official title: The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer, Survival, Aspirin
- Being tested
- Aspirin 75 mg, no aspirin
- Keywords
- Non small cell lung cancer, survival, aspirin
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 75 mgDrug
Also called PL 00142/0377 Activis
Aspirin 75 mg
no aspirinOther
Also called Observation of patients on their pre op medications
nothing
| Study group | Role | What they receive |
|---|---|---|
| Negative control | Placebo comparator | Not on aspirin pre operatively, but refuse to enter trial or have a contraindication to aspirin Receives: Other: no aspirin |
| Aspirin treatment | Experimental | group randomised to aspirin Receives: Drug: Aspirin 75 mg |
| No aspirin treatment | Experimental | Randomised to no aspirin Receives: Other: no aspirin |
| Positive control | Active comparator | Already on aspirin. just observational limb Receives: Drug: Aspirin 75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service
Measured: 5 years
Secondary outcomes (1)
Side effects eg gastrointestinal
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2015 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: failed to achive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Mike Mr Poullis, FRCS(CTh), Principal investigator, Liverpool Heart and Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058902
- Sponsor's protocol ID
- 2010-018360-16
- Status last verified
- Mar 2016
- First submitted
- 26 Jan 2010
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial
- ClinicalTrials.gov ID
- NCT01058902
- Acronym / sponsor ID
- 2010-018360-16
- Conditions
- Non Small Cell Lung Cancer, Survival, Aspirin
- Keywords
- Non small cell lung cancer, survival, aspirin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: failed to achive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 29 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Negative control | Placebo comparator | Other: no aspirinNot on aspirin pre operatively, but refuse to enter trial or have a contraindication to aspirin |
| Aspirin treatment | Experimental | Drug: Aspirin 75 mggroup randomised to aspirin |
| No aspirin treatment | Experimental | Other: no aspirinRandomised to no aspirin |
| Positive control | Active comparator | Drug: Aspirin 75 mgAlready on aspirin. just observational limb |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 75 mgAlso: PL 00142/0377 ActivisAspirin 75 mg | Drug | Aspirin treatment, Positive control |
| no aspirinAlso: Observation of patients on their pre op medicationsnothing | Other | Negative control, No aspirin treatment |
Primary outcome
Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service
Time frame: 5 years
1 secondary outcome
Side effects eg gastrointestinal
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Mr Poullis, FRCS(CTh) principal investigator
Liverpool Heart and Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aspirin 75 mg and no aspirin in people with Non Small Cell Lung Cancer and Survival, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.