Stephens 2005.
Methods | Randomised controlled trial (1995 to 1999) | |
Participants | Patients had microscopically confirmed NSCLC stage T3, N1, M0 or T1‐3, N2, M0 disease, considered by the local thoracic surgeon to be unresectable but to have the potential to become resectable following chemotherapy. | |
Interventions | Radiotherapy group: Thoracic radiotherapy (to be decided by the local radiation oncologist according to the site and extent of the tumour and local practice and around 50‐60Gy over 3‐6 weeks). Chemotherapy group: 4 cycles of chemotherapy at 3‐week intervals followed by surgical resection, if feasible, between 4 and 6 weeks after the final cycle of chemotherapy. |
|
Outcomes | Survival, adverse effects and quality of life. | |
Notes | Although it had been estimated that 350 patients could be recruited in 3 years, only 48 from 12 centres were recruited. Some changes to the protocol were suggested but there was no common agreement about those and the Data and Monitoring and Ethics Committee recommended closing the trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Low risk | Generated by minimisation |
Allocation concealment? | Low risk | 'Clinicians telephoned the Cancer Division of the Medical Research Council Clinical Trials Unit' |
Blinding? All outcomes | Unclear risk | Information not reported |
Incomplete outcome data addressed? All outcomes | Low risk | Description of withdrawals and losses to follow up adequate |