Skip to main content
. 2020 May 21;2020(5):CD011475. doi: 10.1002/14651858.CD011475.pub3

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.
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.
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)
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.