Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer
- Study type
- Clinical trial
- Study name
- SHAPE (CCTG CX.5)
- Phase
- Phase 3
- Design
- Randomised multicentre non-inferiority trial
- Sample size
- 700 patients
- Source
- N Engl J Med · 2024
- Trial registration
- NCT01658930
In plain words
For very small, low-risk cancers of the cervix (2 cm or less), this study showed that simply removing the womb (simple hysterectomy) prevents the cancer from coming back as well as the more extensive "radical" operation, but causes far fewer bladder problems. Choosing this approach requires careful assessment of the pathology and scans.
Key results
Treatment arms and regimens
Simple hysterectomy (removal of the uterus without the parametria and upper vagina) with pelvic lymph node assessment. This is a surgical intervention and has no drug dose.
Radical hysterectomy (with removal of the parametria and upper vagina) with pelvic lymph node assessment. This is a surgical intervention and has no drug dose.
Source of the regimen details: Surgical intervention without a drug regimen; abstract of the paper and ClinicalTrials.gov NCT01658930 (eligibility criteria)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Women with low-risk cervical cancer of squamous, adenocarcinoma or adenosquamous histology: stage IA2 or IB1 (FIGO 2009) with a lesion of 20 mm or less in any dimension and stromal invasion of 10 mm or less on LEEP or cone biopsy (or under 50% on pelvic MRI if only a simple biopsy was done), regardless of lymphovascular space invasion; pelvic MRI and chest imaging before randomisation; fit for surgery and not wishing to preserve fertility. 91.7% stage IB1 (FIGO 2009), 61.7% squamous and 59.3% grade 1 or 2.
Endpoints
Primary outcome: pelvic recurrence at 3 years (prespecified non-inferiority margin: 4 percentage points). Secondary outcomes: urinary complications, survival and quality of life.
Safety and side effects
Simple hysterectomy was associated with less urinary incontinence within the first 4 weeks (2.4% versus 5.5%; P=0.048) and beyond (4.7% versus 11.0%; P=0.003), and less urinary retention within the first 4 weeks (0.6% versus 11.0%) and beyond (0.6% versus 9.9%; both P<0.001).
Clinical significance and place in guidelines
SHAPE led to surgical de-escalation in low-risk disease. The NCCN guideline (version 2.2026), citing the low-risk selection criteria, has adopted conservative surgery (without parametrectomy) as an option for selected stage IA2–IB1 disease. The trial's eligibility criteria (size, depth of invasion, margins and imaging) must be followed exactly.
Limitations
Events were few and median follow-up is 4.5 years; the results apply only to patients meeting the strict low-risk criteria. Some operations were done by minimally invasive surgery, which has been debated since LACC.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.