Methods |
Randomised controlled trial (1963 to 1966) |
Participants |
Patients with locally advanced lung cancer (NSCLC and small cell) who were initially classified as inoperable but were thought to be potentially operable after radiotherapy . Patients were classified as inoperable if they had 1) mediastinal, supraclavicular, or scalene lymph node involvement, 2) chest wall invasion, or 3) encroachment of tumour upon the carina. |
Interventions |
After radiotherapy individuals with cancer that was subsequently considered resectable were randomised to either surgical resection or no surgery. |
Outcomes |
5‐year overall survival, treatment related complications |
Notes |
C‐factor staging: C1
Predates modern staging criteria |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Unclear risk |
'Separate lists of random assignments were prepared for each institution and kept at the statistical center' |
Allocation concealment? |
Low risk |
'The assignment for each new patient was obtained by phone call to the statistical center' |
Blinding?
All outcomes |
Unclear risk |
None described |
Incomplete outcome data addressed?
All outcomes |
Low risk |
'All patients in the study groups were followed until death or through 5 full years of survival' |