Roa 2004.
Study characteristics | ||
Methods | Randomised, phase III trial Treatment period: accrued 1996 to 2001; trial closed in October 2001; at the time of the final analysis, all participants died. |
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Participants | 100 participants with glioblastoma (grade IV astrocytoma) randomised (all aged 60 years and over) from 4 Canadian centres; mean age 72 years; median baseline Karnofsky performance status 70; 58% men and 42% women but 2 participants withdrew after randomization, 1 went to alternative therapy and another 2 others died before starting radiotherapy. | |
Interventions | Arm 1: hypofractionated: 4000 cGy in 15 daily fractions Arm 2: conventional: 6000 cGy in 30 daily fractions; participants randomised to the conventional radiotherapy arm, 4600 cGy in 23 daily fractions was prescribed to the planning target volume (PTV), defined as the preoperative enhancing tumour plus oedema with a 2.0 or 2.5 cm margin. Then 1400 cGy in seven daily fractions was given to the preoperative enhancing tumour (without oedema) plus a 2.5 cm margin. |
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Outcomes | Survival (Kaplan‐Meier curve presented up to 24 months) Quality of life (baseline, 3 weeks, 6 weeks, 3 months, 6 months) Performance status (baseline, 3 weeks, 6 weeks, 3 months, 6 months) Steroid requirements (time point for assessment not described) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Independent computer‐generated randomisation list. |
Allocation concealment (selection bias) | Low risk | Protection of treatment allocation before and until assignment was deemed to be low risk. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Lack of blinding of participants and personnel was associated with low risk of bias for the outcome of survival and unclear risk of bias for quality of life. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Lack of blinding for outcome assessments was associated with low risk of bias for survival and unclear risk of bias for quality of life. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was described with all participants accounted for in terms of survival. The completion rates for quality of life scores was 45% out of all requested quality of life questionnaires given to participants at baseline, 3 weeks, 6 weeks, 3 months and 6 months of follow‐up. The quality of life completion rate was deemed too low to make meaningful comparisons and as such, the authors did not comment on quality of life outcomes. |
Selective reporting (reporting bias) | Unclear risk | Study protocol was available and all of the study's prespecified (primary and secondary) outcomes that were of interest in this review were reported in a prespecified way. Quality of life may be prone to selective reporting. The extent to which selective reporting occurred for quality of life was unknown. |
Other bias | Unclear risk | Size of study bias: 100 participants randomised. |