Brecher 1997.
Methods | Randomised, parallel group, multicentre trial (North America). Analysis stated as by ITT. Withdrawals: stated. | |
Participants | Baseline characteristics: 106 male, 17 female, all participants had stage III disease (Regimen A: 65; Regimen B: 58). Mean age: 8.6 years range 2.3 to 20.3 years.
Tumour staging: Murphy classification.
Diagnosis: histo‐cytologic diagnosis of SNCCL. Entry criteria: newly‐diagnosed stage III SNCCL, pathology confirmed. Exclusion criteria: not stated. |
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Interventions | Regimen A: (COMP given for induction, consolidation with the first three dugs; maintenance with O and MTX and nervous‐system prophylaxis, all given at prespecified intervals) versus Regimen B:(duration of treatment being determined by clinical response). Treatment duration: 9 months. Follow‐up: 3 to 8 years. |
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Outcomes | Overall survival (complete response). Event‐free survival. Remission rate. Relapse rate. | |
Notes | Full text publication. Study type: remission induction. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It was reported that one participant in regimen A was "inevaluable for response". |