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 number | NCT00003159 |
| Secondary identifying numbers | LU22 |
- 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
Scientific
Department of Oncology
Royal Marsden Hospital
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8642 6011 |
|---|---|
| abc@123.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/07/1997 |
| Completion date | 29/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Oncology
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 09/06/2007 | Yes | No |
Editorial Notes
22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
