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	https://doi.org/10.1186/ISRCTN25582437
ClinicalTrials.gov (NCT)	NCT00003159
Protocol serial number	LU22
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Submission date: 06/04/2000
Registration date: 06/04/2000
Last edited: 22/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ian Smith
Scientific

Department of Oncology
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 (0)20 8642 6011
Email	abc@123.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific 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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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
Key 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
Completion date	29/07/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	600
Key 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
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/07/1997
Date of final enrolment	29/07/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Oncology

Sutton
SM2 5PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/06/2007		Yes	No
Plain English results				No	Yes

Editorial Notes

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)