SHAPE
Simple versus radical hysterectomy with lymph-node assessment in women with low-risk cervical cancer (SHAPE)
N = 700NCT01658930
- Population
- Low-risk cervical cancer: lesions of 2 cm or less with limited stromal invasion; 91.7% were FIGO 2009 stage IB1, 61.7% had squamous-cell histology and 59.3% were grade 1 or 2
- Design
- Multicentre, randomised, non-inferiority trial of radical hysterectomy versus simple hysterectomy including lymph-node assessment. Primary outcome: pelvic recurrence at 3 years, with a prespecified non-inferiority margin of 4 percentage points for the between-group difference. 700 patients were randomised, 350 per group.
- Primary endpoint
- Pelvic recurrence
- Arms
- Simple hysterectomy with lymph-node assessment (experimental, n = 350): Simple hysterectomy including lymph-node assessment
- Radical hysterectomy (control, n = 350): Radical hysterectomy with lymph-node assessment
- People
- Plante M, Canadian Cancer Trials Group
Δ 36-month Pelvic recurrence+0.35 pointsΔ Urinary incontinence−3.1 pointsΔ Urinary incontinence−6.3 pointsΔ Urinary retention−10.4 pointsΔ Urinary retention−9.3 points
Show the numbers
| Endpoint | Analysis | Simple hysterectomy with lymph-node assessment | Radical hysterectomy | Effect |
|---|---|---|---|---|
| Pelvic recurrenceRandomised patients (700); the abstract does not name the analysis population and states results were similar in a per-protocol analysis | primarymedian follow-up 4.5 yearsPlante 2024 | 2.52% at 3 y | 2.17% at 3 y | Incidence of pelvic recurrence at 3 years. The absolute difference was 0.35 percentage points (90% CI, -1.62 to 2.32); the interval is a 90% interval, as published, against a prespecified margin of 4 percentage points. |
| Urinary incontinenceRandomised patients (700); the abstract does not name the analysis populationUrinary incontinence within 4 weeks after surgery, as reported | primaryPlante 2024 | 2.4% | 5.5% | P=0.048Secondary outcome reported in the abstract. |
| Urinary incontinenceRandomised patients (700); the abstract does not name the analysis populationUrinary incontinence beyond 4 weeks after surgery, as reported | primaryPlante 2024 | 4.7% | 11% | P=0.003 |
| Urinary retentionRandomised patients (700); the abstract does not name the analysis populationUrinary retention within 4 weeks after surgery, as reported | primaryPlante 2024 | 0.6% | 11% | P<0.001 |
| Urinary retentionRandomised patients (700); the abstract does not name the analysis populationUrinary retention beyond 4 weeks after surgery, as reported | primaryPlante 2024 | 0.6% | 9.9% | P<0.001 |
| Endpoint | Analysis | Simple hysterectomy with lymph-node assessment | Radical hysterectomy | Effect |
|---|---|---|---|---|
| Pelvic recurrenceRandomised patients (700); the abstract does not name the analysis population and states results were similar in a per-protocol analysis | primarymedian follow-up 4.5 yearsPlante 2024 | 2.52% at 3 y | 2.17% at 3 y | Incidence of pelvic recurrence at 3 years. The absolute difference was 0.35 percentage points (90% CI, -1.62 to 2.32); the interval is a 90% interval, as published, against a prespecified margin of 4 percentage points. |
| Urinary incontinenceRandomised patients (700); the abstract does not name the analysis populationUrinary incontinence within 4 weeks after surgery, as reported | primaryPlante 2024 | 2.4% | 5.5% | P=0.048Secondary outcome reported in the abstract. |
| Urinary incontinenceRandomised patients (700); the abstract does not name the analysis populationUrinary incontinence beyond 4 weeks after surgery, as reported | primaryPlante 2024 | 4.7% | 11% | P=0.003 |
| Urinary retentionRandomised patients (700); the abstract does not name the analysis populationUrinary retention within 4 weeks after surgery, as reported | primaryPlante 2024 | 0.6% | 11% | P<0.001 |
| Urinary retentionRandomised patients (700); the abstract does not name the analysis populationUrinary retention beyond 4 weeks after surgery, as reported | primaryPlante 2024 | 0.6% | 9.9% | P<0.001 |