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ISRCTN
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ISRCTN25582437
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DOI
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10.1186/ISRCTN25582437
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ClinicalTrials.gov identifier
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NCT00003159
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EudraCT number
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Public title
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Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small cell lung cancer (NSCLC) of any stage
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Scientific title
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Acronym
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N/A
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Serial number at source
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LU22
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Study hypothesis
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To compare survival following surgical resection with or without pre-operative chemotherapy.
Secondary aims are to compare:
1. QL throughout the survival period; all items on the SF-36 questionnaire will be used to assess physical, emotional and functional health status, with particular emphasis on items that reflect the impact of symptoms on activities
2. Pre-randomisation clinical and post-surgery pathological staging
3. Resectability rates
4. Extent of surgery
5. Time to and site of relapse
And chemotherapy group, to document response evaluated according to the subjective investigator’s opinion following the WHO (1979) criteria, and clinician's assessment of the adverse effects of chemotherapy.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Non-small cell lung cancer (NSCLC)
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Participants - inclusion criteria
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1. Previously untreated non small cell lung cancer
2. Tumour considered resectable
3. Either sex, any age
4. No evidence of distant metastases
5. Considered fit for chemotherapy and proposed surgical resection
6. WHO performance status 0, 1 or 2
7. No contraindication to chemotherapy or surgery
8. No other disease or previous malignancy likely to interfere with the protocol treatments
9. Patient willing and able to complete SF-36 questionnaires
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/07/1997
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Anticipated end date
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29/07/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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600
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Interventions
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1. One group receives surgical resection with pre-operative chemotherapy.
2. The other group receives surgical resection alone.
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Primary outcome measure(s)
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Survival, quality of life, pre-randomisation clinical and post-surgery pathological staging, resectability rates, extent of surgery, time to and site of relapse
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Secondary outcome measure(s)
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1. QL assessed before randomisation at 6 and 12 months from randomisation, and then annually, using the SF-36 questionnaire. All items and subscales will be examined according to the SF-36 manual. Analysis will be based on comparisons between regimens at the designated time points and on change from baseline for each regimen
2.Pre-randomisation clinical and post-surgery pathological staging
3. Resectability rates
4. Extent of surgery
5. Time to and site of relapse
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17544497
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Contact name
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Prof
Ian
Smith
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Address
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Department of Oncology
Royal Marsden Hospital
Downs Road
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City/town
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Sutton
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Zip/Postcode
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SM2 5PT
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Country
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United Kingdom
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Tel
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+44 (0)20 8642 6011
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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06/04/2000
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Last edited
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04/09/2009
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Date ISRCTN assigned
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06/04/2000
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