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Can robotic surgery match open surgery in beating cervical cancer?

NCT ID NCT03719547

Disease control Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This trial asks whether robot-assisted hysterectomy is as effective as traditional open surgery for treating early-stage cervical cancer. About 800 women with stage IB (excluding IB3) or IIA1 cervical cancer will be randomly assigned to one of the two surgical approaches. The main goal is to compare how long women remain free of cancer recurrence after surgery. The study also tracks overall survival and surgical complications to help guide future treatment choices.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robot-assisted radical hysterectomy (compared to open abdominal radical hysterectomy)
What this could lead to
If robot-assisted surgery proves as effective as open surgery, it could offer a less invasive option with similar cancer control for early-stage cervical cancer.
What could go wrong
The trial is large but results are not yet available; robot-assisted surgery may not match open surgery in preventing recurrence, and there are risks of surgical complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 800 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix; * Patients with histologically confirmed stage IB (IB3 excluded) and IIA1, according to the latest revision of the FIGO staging manual * Patients undergoing either a Type B or C radical hysterectomy (Querleu and Morrow classification) * Patients with adequate bone marrow, renal and hepatic function * ECOG Performance Status of 0, 1 or 2. * Patient must be suitable candidates for surgery. * Patients who have signed an approved Informed Consent * Age 18 years or older Exclusion Criteria: * Any histology other than adenocarcinoma, squamous cell carcinoma or adeno-squamous carcinoma of the uterine cervix * Tumor size greater than 4 cm * FIGO stage II-IV (except IIA1) * Patients with a history of pelvic or abdominal radiotherapy * Patients who are pregnant * Patients with contraindications to surgery * Patients with evidence of metastatic disease by conventional imaging, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes * Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Patients unable to withstand prolonged lithotomy and steep Trendelenburg position * Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1N0M0 grade 1 or 2 without any signs of recurrence or activity)

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Recurrence Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Karolinska University Hospital

    RECRUITING

    Stockholm, 17176, Sweden

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