Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01058902
Status:
WITHDRAWN
Last Update Posted:
2016-03-07
First Post:
2010-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect Of Aspirin On Survival in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'C488176', 'term': 'N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'failed to achive funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-04', 'studyFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2010-01-28', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Side effects eg gastrointestinal', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Non small cell lung cancer', 'survival', 'aspirin'], 'conditions': ['Non Small Cell Lung Cancer', 'Survival', 'Aspirin']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nMethodology 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.\n\nStudy 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.\n\nContamination of control limb\n\nPatients 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.\n\nIf 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.\n\nData collection This will be prospective via a secure web server, hosted on an NHS computer located in a secure NHS IT locked room.\n\nStudy procedures No invasive procedure, samples or tissues will be performed or obtained in any patients.\n\nStudy intervention Aspirin 75 mg/day or no tablet taken for a period of 5 years after randomisation.\n\nReducing adverse events\n\nAll 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.\n\nMonitoring 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.\n\nSpecific adverse events we will be following include:\n\nStopping trial medication secondary to side effects, GI bleeds, stomach ulcers, anaemia that require hospital admission and Blood transfusion(s)\n\nData 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.\n\nIf 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.\n\nThe 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.\n\nGP contacts All GPs will be informed of their patients inclusion in this trial.\n\nStatistical analysis. This will be performed by Dr Mark Jackson or a delegated member of his team, at Liverpool Heart and Chest Hospital.\n\nSample 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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.'}, 'identificationModule': {'nctId': 'NCT01058902', 'briefTitle': 'The Effect Of Aspirin On Survival in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Liverpool Heart and Chest Hospital NHS Foundation Trust'}, 'officialTitle': 'The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial', 'orgStudyIdInfo': {'id': '2010-018360-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Negative control', 'description': 'Not on aspirin pre operatively, but refuse to enter trial or have a contraindication to aspirin', 'interventionNames': ['Other: no aspirin']}, {'type': 'EXPERIMENTAL', 'label': 'Aspirin treatment', 'description': 'group randomised to aspirin', 'interventionNames': ['Drug: Aspirin 75 mg']}, {'type': 'EXPERIMENTAL', 'label': 'No aspirin treatment', 'description': 'Randomised to no aspirin', 'interventionNames': ['Other: no aspirin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive control', 'description': 'Already on aspirin. just observational limb', 'interventionNames': ['Drug: Aspirin 75 mg']}], 'interventions': [{'name': 'Aspirin 75 mg', 'type': 'DRUG', 'otherNames': ['PL 00142/0377 Activis'], 'description': 'Aspirin 75 mg', 'armGroupLabels': ['Aspirin treatment', 'Positive control']}, {'name': 'no aspirin', 'type': 'OTHER', 'otherNames': ['Observation of patients on their pre op medications'], 'description': 'nothing', 'armGroupLabels': ['Negative control', 'No aspirin treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L14 3PE', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Mike Mr Poullis, FRCS(CTh)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Liverpool Heart and Chest Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool Heart and Chest Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mike Poullis, Consultant Cardiothoracic Surgeon', 'oldOrganization': 'Liverpool Heart and Chest Hospital NHS Foundation Trust'}}}}