| Methods |
Multicentre European RCT; 650 recruited between Jan 1995 to Dec 2004, 5 excluded due to inclusion criteria not being met. Stratification was done per centre and group allocation was concealed by closed envelopes. |
| Participants |
645 women with low‐risk, Stage IA‐IB endometrial cancer of Grade 1‐2. |
| Interventions |
Surgery and VBT (319 women) versus surgery alone (326 women). Surgery included TAH and BSO, node sampling and peritoneal washing. Lymphadenectomy was performed at one of the six participating centres. Time between surgery and VBT was 4 to 8 weeks; total dose ranged from 18 to 40 Gy. VBT given on outpatient basis. |
| Outcomes |
Overall survival, locoregional recurrence and toxicity. |
| Notes |
Mean follow‐up was 68 months (range 2‐151 months). Baseline characteristics were comparable. Four vaginal recurrences occurred in the VBT group versus. 10 in the control group. Late treatment side‐effects were mainly grade 1‐2 (EORTC criteria). Vaginal side‐effects were worse in the VBT group (28 versus 5, P = 0.00004). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Central randomisation with stratification by centre. |
| Allocation concealment (selection bias) |
Low risk |
Sealed envelopes. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Outcome assessors were blind to group allocations. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Low attrition. |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported. Analyses by ITT. |
| Other bias |
Low risk |
High quality trial. |
