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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
ISRCTN ISRCTN25582437
DOI 10.1186/ISRCTN25582437
ClinicalTrials.gov identifier NCT00003159
EudraCT number
Public title Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small cell lung cancer (NSCLC) of any stage
Scientific title
Acronym N/A
Serial number at source LU22
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Non-small cell lung cancer (NSCLC)
Participants - inclusion criteria 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
Participants - exclusion criteria Not provided at time of registration.
Anticipated start date 01/07/1997
Anticipated end date 29/07/2004
Status of trial Completed
Patient information material
Target number of participants 600
Interventions 1. One group receives surgical resection with pre-operative chemotherapy.
2. The other group receives surgical resection alone.
Primary outcome measure(s) Survival, quality of life, pre-randomisation clinical and post-surgery pathological staging, resectability rates, extent of surgery, time to and site of relapse
Secondary outcome measure(s) 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
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17544497
Contact name Prof  Ian  Smith
  Address Department of Oncology
Royal Marsden Hospital
Downs Road
  City/town Sutton
  Zip/Postcode SM2 5PT
  Country United Kingdom
  Tel +44 (0)20 8642 6011
  Email
Sponsor Medical Research Council (MRC) (UK)
  Address 20 Park Crescent
  City/town London
  Zip/Postcode W1B 1AL
  Country United Kingdom
  Tel +44 (0)20 7636 5422
  Fax +44 (0)20 7436 6179
  Email clinical.trial@headoffice.mrc.ac.uk
  Sponsor website: http://www.mrc.ac.uk
Date applied 06/04/2000
Last edited 04/09/2009
Date ISRCTN assigned 06/04/2000
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