SHAPE Trial: Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer

Simple Hysterectomy Safe for Some Cervical Cancers - PubMed
Findings from the SHAPE trial confirm that carefully selected women with early-stage cervical cancer can undergo a simple hysterectomy instead of a radical procedure without increasing their risk of disease recurrence. The findings are likely to set a new global standard of care for patients with lo …

Year of Publication



Simple hysterectomy is non-inferior to radical hysterectomy in preventing pelvic recurrence in patients with low-risk early-stage cervical cancer.

Inclusion Criteria Table

Criteria Details
FIGO Stage (2009) IA2 or IB1
Lesion Size ≤2 cm
Depth of Stromal Invasion <10 mm on LEEP or Cone; MRI <50% stromal invasion
Lymph Node Metastasis No evidence on preoperative imaging
Histologic Subtypes Squamous or adenocarcinoma or adenosquamous(Excludes other than specified for low-risk)
  • LVSI was not an exclusion criteria
  • Choice of Open vs. MIS left to surgeon

Exclusion Criteria

Lesions >2 cm, evidence of metastatic disease on preoperative imaging, other histologic subtypes.

Primary Endpoint

Pelvic recurrence within 3 years post-operation.

Experimental Arm(s)

Simple hysterectomy including lymph-node assessment.

Control Arm (or standard therapy)

Radical hysterectomy (type II) including lymph-node assessment.

Results Table with More Details

  • 700 patients (350 in each group)
  • 92% 1B1 patients
  • 62% SCC
  • 80% Prior Leep or cone
  • 83% MIS cases in Simple Hyst Arm; 71% MIS cases in Rad Hyst Arm

Outcome Simple Hysterectomy Group Radical Hysterectomy Group P-value Hazard Ratio
3-Year Pelvic Recurrence Rate 3.2% 3.5% NS NA
Urinary Incontinence 2.4% 5.5% 0.048 NA
Urinary Retention (<4 weeks) 0.6% 11% <0.001 NA
Urinary Retention (beyond 4 weeks) 0.6% 9.9% <0.001 NA
Intr-op Injury 7.1% 6.4% NS NA

Pelvic Recurrence Rates by Surgical Type and Approach

Group Surgical Approach Patients (N) Pelvic Recurrences (N) Recurrence Rate (%)
Simple Hysterectomy Minimally Invasive 281 9 3.2
Simple Hysterectomy Open Surgery 57 2 3.5
Radical Hysterectomy Minimally Invasive 243 7 2.9
Radical Hysterectomy Open Surgery 99 3 3.0


Simple hysterectomy is not inferior to radical hysterectomy regarding the 3-year incidence of pelvic recurrence and presents a lower risk of urinary complications.


  • Small number of events leading to wide confidence intervals.
  • Follow-up period (median of 4.5 years) may not capture all recurrences.
  • Surgical approach (open vs. minimally invasive) was not a stratification factor.
  • Results may not be generalizable to non-low-risk patients or underrepresented populations.

Criteria SHAPE Trial (Plante et al. 2024) CONCERV Trial (Schmeler et al. 2021)
FIGO Stage IA2 or IB1 IA2–IB1
Histology Squamous or adenocarcinoma or adenosquamous (any grade) Squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only)
Tumor Size ≤2 cm <2 cm
Lymphovascular Space Invasion (LVSI) Allowed No LVSI allowed
Depth of Stromal Invasion <10 mm or <50% on MRI <10 mm (histology only)
Metastatic Disease Negative imaging for metastatic disease Negative imaging for metastatic disease with CT scan, MRI, and/or PET scan
Conization Margins Positive Conization Margins allowed Must have negative conization margins
Recurrence rate at 3 years 3.6% 3.5%