Randomised trial of surgical resection with or without pre-operative chemotherapy in patients with operable non-small cell lung cancer (NSCLC) of any stage
Not Applicable
Completed
- Conditions
- on-small cell lung cancer (NSCLC)CancerLung cancer
- Registration Number
- ISRCTN25582437
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17544497
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 600
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
Exclusion Criteria
Not provided at time of registration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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<br>2.Pre-randomisation clinical and post-surgery pathological staging<br>3. Resectability rates<br>4. Extent of surgery<br>5. Time to and site of relapse