Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
04/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ian Smith

ORCID ID

Contact details

Department of Oncology
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
+44 (0)20 8642 6011

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 investigatorÂ’s 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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17544497

Publication citations

  1. 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.

Additional files

Editorial Notes