The Effect Of Aspirin On Survival in Lung Cancer

March 4, 2016 updated by: Liverpool Heart and Chest Hospital NHS Foundation Trust

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Negative control
Not on aspirin pre operatively, but refuse to enter trial or have a contraindication to aspirin
Other: no aspirin
nothing
Other Names:
  • Observation of patients on their pre op medications
Experimental: Aspirin treatment
group randomised to aspirin
Drug: Aspirin 75 mg
Aspirin 75 mg
Other Names:
  • PL 00142/0377 Activis
Experimental: No aspirin treatment
Randomised to no aspirin
Other: no aspirin
nothing
Other Names:
  • Observation of patients on their pre op medications
Active Comparator: Positive control
Already on aspirin. just observational limb
Drug: Aspirin 75 mg
Aspirin 75 mg
Other Names:
  • PL 00142/0377 Activis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects eg gastrointestinal
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Investigators

  • Principal Investigator: Mike Mr Poullis, FRCS(CTh), Liverpool Heart and Chest Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

January 29, 2010

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-018360-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Clinical Trials on no aspirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe