Fox 1973.
Methods | Parallel randomised controlled trial | |
Participants | Adults with SCLC diagnosed on bronchial biopsy, with no radiologic evidence of extrathoracic metastases, and appropriate for operation/radiotherapy. | |
Interventions | Surgery ‐ 71 participants Complete resection in 34 (48%), thoracotomy in 24 (34%), resection in 23 (33%), refused surgery in 2, and no surgery prior to deterioration in 13 (18%) of participants. In 55% of the surgical arm participants, treatment other than surgery was given at some time during the 2‐year period: chest radiotherapy was given to 34% in the first 3 months; radiotherapy for distant metastases was given in 11%; and chemotherapy was given to 18%. Compared to radiotherapy ‐ 73 participants. Radical (3000 rads over 20 to 40 days) in 62 (85%), palliative in 8 (11%), and refused or deteriorated in 3 (4%) of participants. 29% of radiotherapy arm participants received further treatment over the 2‐year period: 21% received radiotherapy for distant metastases; and chemotherapy was administered to 12% of participants. |
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Outcomes |
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Notes | This is the same cohort as the Scadding and Miller trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation to treatment was made by reference to lists based on random sampling numbers. |
Allocation concealment (selection bias) | Low risk | A separate list was used for each surgeon. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | It is likely that participants were aware of the intervention they were assigned to. It is likely the treating physicians were aware of the intervention received and this may have affected the choice of co‐interventions. Lack of blinding is unlikely to have affected the results in the main outcome of survival but may have an effect on the measurement of other outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It was not clear whether outcome assessors were truly blinded to the intervention. Lack of blinding is unlikely to have affected the results in the main outcome of survival, but it is unclear how it may have affected other outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Withdrawals were not equal across groups, with 13/71 in the surgical group and only 3/73 in the radiotherapy group dropping out. For the surgical group 13/71 participants did not receive the intervention; 11 deteriorated in the interval between the allocation to treatment and the planned date of the operation, so that they were then judged unfit for surgery, and 2 refused surgery. In the radiotherapy group 3/73 participants did not receive any radiotherapy, in 2 because of deterioration before treatment could be commenced; the 3rd refused radiotherapy. There may have been a long delay between allocation of treatment and actual commencement, especially in the surgical group, which could have affected results. |
Selective reporting (reporting bias) | Low risk | The study fully reported all prespecified outcomes. |
Other bias | High risk | Participants were eligible to receive further treatment following randomised intervention. Intention to treat analysis was performed. |