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The Effect Of Aspirin On Survival in Lung Cancer

This study has been withdrawn prior to enrollment.
(failed to achive funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01058902
First Posted: January 29, 2010
Last Update Posted: March 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Liverpool Heart and Chest Hospital NHS Foundation Trust
  Purpose
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.

Condition Intervention Phase
Non Small Cell Lung Cancer Survival Aspirin Drug: Aspirin 75 mg Other: no aspirin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect Of Aspirin On Survival Following Potentially Curative Resection Of Non Small Cell Carcinoma Of The Lung The Big A Trial

Resource links provided by NLM:


Further study details as provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:

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

Secondary Outcome Measures:
  • Side effects eg gastrointestinal [ Time Frame: 5 years ]

Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Observation of patients on their pre op medications
Experimental: Aspirin treatment
group randomised to aspirin
Drug: Aspirin 75 mg
Aspirin 75 mg
Other Name: PL 00142/0377 Activis
Experimental: No aspirin treatment
Randomised to no aspirin
Other: no aspirin
nothing
Other Name: 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 Name: PL 00142/0377 Activis

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058902


Locations
United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, Merseyside, United Kingdom, L14 3PE
Sponsors and Collaborators
Liverpool Heart and Chest Hospital NHS Foundation Trust
Investigators
Principal Investigator: Mike Mr Poullis, FRCS(CTh) Liverpool Heart and Chest Hospital
  More Information

Responsible Party: Mike Poullis, Consultant Cardiothoracic Surgeon, Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01058902     History of Changes
Other Study ID Numbers: 2010-018360-16
First Submitted: January 26, 2010
First Posted: January 29, 2010
Last Update Posted: March 7, 2016
Last Verified: March 2016

Keywords provided by Liverpool Heart and Chest Hospital NHS Foundation Trust:
Non small cell lung cancer
survival
aspirin

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics