# SHAPE (CCTG CX.5)

Source: https://onco.cc/trials/shape/  
OnCo record `shape` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

SHAPE showed that women with small, low-risk cervical cancers can safely have a simple hysterectomy rather than the more extensive radical operation, with the same low rate of recurrence and fewer bladder and sexual problems.

## Summary

Radical hysterectomy removes the parametrial tissue and upper vagina along with the uterus and carries lasting urinary, bowel and sexual side effects. SHAPE, run by the Canadian Cancer Trials Group with the Gynecologic Cancer InterGroup, randomised 700 women with low-risk early cervical cancer (2 cm or less, less than 10 mm of stromal invasion, no node involvement on imaging) to simple or radical hysterectomy, both with pelvic node assessment. The primary endpoint was pelvic recurrence at three years, tested for non-inferiority.

Pelvic recurrence at three years was low and non-inferior with simple hysterectomy, and urinary incontinence and retention were less frequent. The result, published in the New England Journal of Medicine in 2024, made simple hysterectomy a standard for this carefully defined low-risk group and reversed the trend towards ever more radical surgery.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Also known as: SHAPE; CX.5; GCIG SHAPE
- Tags: subtype-trials
- Registry id: NCT01658930
- Phase: 3
- Setting: Low-risk early-stage cervical cancer (stage IA2 or IB1, 2 cm or less, limited stromal invasion): simple hysterectomy against radical hysterectomy, both with pelvic lymph node assessment
- Sponsor: Canadian Cancer Trials Group
- Enrolled: 700
- Result: Simple hysterectomy was non-inferior to radical hysterectomy for three-year pelvic recurrence in low-risk early cervical cancer, with fewer urinary complications.

## Sources

- ClinicalTrials.gov NCT01658930: https://clinicaltrials.gov/study/NCT01658930

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Early cervical cancer and fertility-sparing surgery](https://onco.cc/cancers/early-cervical-cancer/)
- people: [Marie Plante](https://onco.cc/people/marie-plante/)
- key papers: [SHAPE: simple versus radical hysterectomy in low-risk early cervical cancer](https://onco.cc/key-papers/paper-shape-nejm-2024/)

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