A trial looking at surgery for cervical cancer (SHAPE)

Cancer type:

Cervical cancer

Status:

Results

Phase:

Phase 3

This trial compared two different operations for cervical cancer. It was for women with early stage Open a glossary item cervical cancer who had a low risk of their cancer coming back. 

The trial was supported by Cancer Research UK. It was open for people to join between 2012 and 2019. The team published the results in 2024.

More about this trial

Doctors often treat early stage cervical cancer with an operation called a hysterectomy. When this trial was done, women often had a radical hysterectomy

A radical hysterectomy involves removal of:

  • the cervix
  • the womb
  • the upper part of the vagina
  • all the tissues that hold the womb in place (connective tissue)
  • the lymph nodes Open a glossary item around the womb

This often works very well. But it can cause side effects. 

Researchers hoped a smaller operation called a simple hysterectomy may be as good as a radical hysterectomy. And cause fewer short term and long term side effects.

A simple hysterectomy involves the removal of:

  • the cervix
  • the womb
  • a small part of the upper vagina
  • the lymph nodes around the womb

The main aims of this trial were to find out:

  • if a simple hysterectomy works as well as a radical hysterectomy 
  • more about the side effects
  • how both operations affect people’s quality of life Open a glossary item 

Summary of results

This trial showed that the cancer came back in a similar number of people who had a simple hysterectomy and a radical hysterectomy.

Results
A total of 700 women joined this trial. They were all due to have surgery for cervical cancer. They were put into one of two treatment groups at random:

  • half had a radical hysterectomy
  • half had a simple hysterectomy

The research team looked at how many people’s cancer came back within the pelvic area (pelvis Open a glossary item), 3  years after joining the trial. This could include cancer in areas such as the vagina, the connective tissue and lymph nodes.

They found it was similar in both groups:

  • 10 out of 350 women (2.9%) in the radical hysterectomy group
  • 11 out of 350 women (3.1%) in the simple hysterectomy group

They also looked at how many people had died. This was 7 people in each group. Some died because of their cancer. And some died for other reasons.

Side effects
The team looked at how many people had complications during their operation. This was similar in both groups:

  • 22 out of 344 women (6.4%) who had a radical hysterectomy
  • 24 out of 338 women (7.1%) who had a simple hysterectomy

They also looked at the number of people who had at least one side effect within 4 weeks of their operation. They found it was:

  • 174 women (51%) who had a radical hysterectomy
  • 144 women (43%) who had a simple hysterectomy

The number of people who had at least one side effect beyond 4 weeks after their operation was:

  • 208 women (61%) who had a radical hysterectomy
  • 181 women (54%) who had a simple hysterectomy

The most common side effects in both groups were tummy (abdominal) pain, constipation and extreme tiredness (fatigue).

The team looked at the number of people who had bladder related problems such as urine leakage (incontinence) or difficulty passing urine (retention).

The number of people who had urinary incontinence for more than 4 weeks after surgery was:

  • 38 women (11%) who had a radical hysterectomy
  • 16 women (5%) who had a simple hysterectomy

The number of people who had urinary retention for more than 4 weeks after surgery was:

  • 34 women (10%) who had a radical hysterectomy
  • 2 women (less than 1%) who had a simple hysterectomy

Conclusion
The trial team concluded a simple hysterectomy was as good as a radical hysterectomy for cervical cancer. This is for women who have early stage cancer that has a low risk of coming back after surgery. They also found that it caused fewer urinary problems.

More detailed information
There is more information about this research in the reference below. 

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer
M Plante and others
New England Journal of Medicine, 2024. Volume 390, pages 819-829.

Where this information comes from    
We have based this summary on the information in the article above. This has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. We have not analysed the data ourselves. 

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor John Tidy

Supported by

Cancer Research UK
Canadian Cancer Trials Group (formerly NCIC)
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)

Other information

This is Cancer Research UK trial number CRUK/13/015.

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10674

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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