The Effect Of Aspirin On Survival in Lung Cancer

NCT01058902 | Withdrawn Phase 3 DMC

• 1 other identifier: 2010-018360-16
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer; Survival; Aspirin

Keywords

Non small cell lung cancer; survival; aspirin

Outcome Measures

Primary Outcomes (1)

• Survival - alive or dead (A standard cancer trial outcome). This will be assessed via the UK national strategic tracking service

  5 years

Secondary Outcomes (1)

• Side effects eg gastrointestinal

  5 years

Study Arms (4)

Negative control

PLACEBO COMPARATOR

Not on aspirin pre operatively, but refuse to enter trial or have a contraindication to aspirin

Other: no aspirin

Aspirin treatment

EXPERIMENTAL

group randomised to aspirin

Drug: Aspirin 75 mg

No aspirin treatment

EXPERIMENTAL

Randomised to no aspirin

Other: no aspirin

Positive control

ACTIVE COMPARATOR

Already on aspirin. just observational limb

Drug: Aspirin 75 mg

Interventions

Aspirin 75 mg DRUG

Aspirin 75 mg

Also known as: PL 00142/0377 Activis

Aspirin treatment; Positive control

no aspirin OTHER

nothing

Also known as: Observation of patients on their pre op medications

Negative control; No aspirin treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Aspirin; N-acetyl-S-(alpha-methyl-4-(2-methylpropyl)benzeneacetyl)cysteine 4-(nitrooxy)butyl ester

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mike Mr Poullis, FRCS(CTh)

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 26, 2010
• First Posted: January 29, 2010
• Study Start: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2020
• Last Updated: March 7, 2016

Record last verified: 2016-03

Locations

GB (1)