Sorbe 2011.
| Methods | RCT conducted at five Swedish centres. 562 women recruited between 1997 to 2008. Scanty methodological details provided in report. | |
| Participants | 527 women with 'medium‐risk' endometrial cancer defined as: FIGO Stage I (surgical staging); endometrioid histological type; the presence of Grade 3 or deep myometrial infiltration or DNA aneuploidy; nuclear Grade l‐2; pathologically negative lymph nodes; and negative abdominal cytology. Last two points were optional for this study and data were not available for all cases. Lymphovascular space invasion was not regularly included in the pathology reports at the participating centres and was not included in the definition of the medium‐risk group. Primary surgery consisted of TAH, BSO, appendectomy, node sampling of enlarged nodes, and peritoneal washings with cytology. Routine lymphadenectomy was not performed. | |
| Interventions | EBRT+VBT (264 women) versus VBT only (263 women). Time to intervention was between 4‐8 weeks post‐surgery. All VBT was given as on an outpatient basis (EQD2 total dose of 19.5 to 23.5 Gy at 5mm). EBRT was given as five fractions per week to a total dose of 46 Gy. | |
| Outcomes | Primary: Locoregional recurrence and overall survival. Secondary: recurrence‐free survival, recurrence‐free interval, cancer‐specific survival and toxicity. QOL assessed at baseline, 3 months and one year will be presented in a separate report. |
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| Notes | Attrition: 14 patients not eligible, 15 patients withdrawn for personal reasons and five lost to follow‐up, therefore 34/562 excluded (21 in EBRT/VBT versus 14 in the VBT group). Median follow‐up = 62 months (range 12 to 138 months). |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | 'Randomised' ‐ no details provided. |
| Allocation concealment (selection bias) | Unclear risk | No details provided. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 562 enrolled; 34/562 excluded from analyses including five lost to follow‐up. |
| Selective reporting (reporting bias) | Low risk | Prespecified outcomes and all expected outcomes of interest reported. |
| Other bias | Low risk | Medium to low risk. Participant and tumour characteristics were similar between groups (FIGO Stage IA and DNA aneuploidy slightly higher in EBRT+VBT). Trial methodology unclear. Additional methodological details requested from authors. |
BSO: bilateral salpingo‐oophorectomy EBRT: external beam radiotherapy GI: gastro‐intestinal GU: genito‐urinary ITT: intention‐to‐treat NAT: no additional treatment QOL: quality of life RT: radiotherapy TAH: total abdominal hysterectomy VBT: vaginal brachytherapy