Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003159
Protocol/serial number
LU22
Study information
Scientific title
Acronym
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 investigators opinion following the WHO (1979) criteria, and clinician's assessment of the adverse effects of chemotherapy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Non-small cell lung cancer (NSCLC)
Intervention
1. One group receives surgical resection with pre-operative chemotherapy.
2. The other group receives surgical resection alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/07/1997
Overall trial end date
29/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
600
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/07/1997
Recruitment end date
29/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Oncology
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17544497
Publication citations
-
Results
Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R, Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review., Lancet, 2007, 369, 9577, 1929-1937, doi: 10.1016/S0140-6736(07)60714-4.