SHAPE
In carefully selected patients with low-risk early-stage cervical cancer, can simple hysterectomy replace radical hysterectomy without compromising pelvic control?
Population and eligibility
700 patients with low-risk cervical cancer, principally FIGO 2009 IA2–IB1, lesions ≤2 cm; pelvic lymph-node assessment was performed.
700 participants (reported trial population; confirm exact analysis population in primary report)
Simple hysterectomy vs radical hysterectomy.
Pelvic recurrence
3 years
Registry: NCT01658930.
Key results and relative effect
Three-year pelvic recurrence 2.52% after simple hysterectomy vs 2.17% after radical hysterectomy. Absolute difference 0.35 percentage points; 90% CI −1.62 to 2.32 percentage points. Simple hysterectomy met the prespecified non-inferiority criterion.
Pelvic recurrence · 3 years
Bars scale to the larger displayed value. For median time-to-event endpoints, bars show median duration—not absolute event probability.
Absolute Effect
Endpoint and horizon: Pelvic recurrence at 3 years.
NNT: Do not calculate conventional NNT for the non-inferiority result; the relevant trade-off is similar pelvic control with less urological morbidity.
NNH: Not calculated unless a defensible fixed-time excess-harm risk difference is established. Do not infer NNH from relative effects or mixed adverse-event definitions.
Trial-specific toxicity and treatment burden
Simple hysterectomy reduced urinary morbidity, including bladder and ureteral complications, compared with radical hysterectomy. Full grade-specific harms and QoL need verification from the primary report.
Full grade 3–5 toxicity, discontinuation, treatment exposure, patient-reported outcomes and quality-of-life details must be extracted from the complete primary report/supplement before final clinical signoff. No unreported rates are imputed.
Subgroups, maturity and limitations
This is a non-inferiority/de-escalation result, not evidence that simple hysterectomy is superior. Applicability depends on strict low-risk eligibility, tumour size, stromal invasion and nodal assessment.
Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Later analyses may use different cutoffs and safety definitions.
Clinical interpretation
This summary is not a substitute for contemporary disease-specific guidance or multidisciplinary assessment. Confirm eligibility, organ function, biomarkers, competing risks and patient priorities before applying trial results.
Primary source and registry
Primary publication / authoritative source ↗
ClinicalTrials.gov NCT01658930 ↗
Source-level audit of all reported endpoints, QoL, treatment discontinuation, exact analysis populations and current guideline context remains required before this page can be labelled fully clinically verified.