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The Effect Of Aspirin On Survival in Lung Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2010 by Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor:
Information provided by:
Liverpool Heart and Chest Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01058902
First received: January 26, 2010
Last updated: January 28, 2010
Last verified: January 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects eg gastrointestinal [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058902

Contacts
Contact: Mike Mr Poullis, FRCS(CTh) 0151 228 1616 mike.poullis@lhch.nhs.uk
Contact: Mark Mr Jackson, PHd 0151 228 1616 mark.jackson@lhch.nhs.uk

Locations
United Kingdom
Liverpool Heart and Chest Hospital Not yet recruiting
Liverpool, Merseyside, United Kingdom, L14 3PE
Contact: Mike Poullis, FRCS(CTh)    0151 228 1616    mike.poullis@lhch.nhs.uk   
Principal Investigator: Mike Poullis, FRCS(CTh)         
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

Additional Information:
No publications provided

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
Study First Received: January 26, 2010
Last Updated: January 28, 2010
Health Authority: United Kingdom: Department of Health

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

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

ClinicalTrials.gov processed this record on November 24, 2014