Lad 1994a.
Methods | Parallel randomised trial | |
Participants | Adults with SCLC diagnosed on bronchial biopsy, with no radiologic evidence of extrathoracic metastases, and appropriate for operation/radiotherapy | |
Interventions | All participants had induction chemotherapy for 5 cycles prior to randomisation (cyclophosphamide, 1 g/m²; doxorubicin, 50 mg/m²; and vincristine, 1.4 mg/m², every 3 weeks for five cycles). Surgery ‐ 70 participants. Complete resection in 77% of surgical participants, with 6% resulting in incomplete resection (positive margins), and 17% considered unresectable at time of thoracotomy. Compared to no intervention ‐ 76 participants. Following, all had chest and brain irradiation. (The radiation therapy doses were 50 Gy in 25 fractions to the chest, the target being the initial (pre‐chemotherapy) tumour volume and mediastinum, and 30 Gy in 15 fractions whole‐brain prophylaxis. Brain and chest irradiation were delivered concurrently). |
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Outcomes | Median survival, loco‐regional progression. Adverse events, including treatment related deaths, were not reported. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study was reported as randomised, but no details for methods were given. |
Allocation concealment (selection bias) | Unclear risk | No details for allocation concealment were given. |
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 | Low risk | All participants were accounted for. |
Selective reporting (reporting bias) | Low risk | The study fully reported all prespecified outcomes. |
Other bias | Unclear risk | It was not clear if any participants crossed over to other intervention arms. |