The Effect Of Aspirin On Survival in Lung Cancer
This study is not yet open for participant recruitment.
Verified January 2010 by Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
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
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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
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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics |
ClinicalTrials.gov processed this record on May 16, 2013