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Vulvar cancer study aims to spare women from unnecessary surgery

NCT ID NCT06476639

Disease control Sponsor: Queensland Centre for Gynaecological Cancer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether regular ultrasound checks of the groin can safely replace the standard surgery to remove lymph nodes in women with early-stage vulvar cancer. The goal is to reduce side effects and improve recovery while still keeping the cancer under control. About 640 women will take part, and the study will compare survival rates and quality of life between the two approaches.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 640 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2035

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva * Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease * Willing and able to undergo IFL/SNB according to local clinical practice management guidelines * Willing and able to comply with all study requirements, timing and/or nature of required assessments. * Signed written informed consent * Negative (serum or urine) pregnancy (BHCG) test ≤ 30 days of surgery ONLY in pre-menopausal women and women \< 2 years after the onset of menopause. Exclusion Criteria: * Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease) * Clinical or medical imaging evidence of regional and/or distant metastatic disease * Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Other prior malignancies \<5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ * Estimated life expectancy of ≤6 months

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Conditions

The condition(s) this trial relates to.

Lymphatic Metastasis metastatic malignant neoplasm in the lymph nodes vulva cancer vulvar carcinoma

As listed by the trial registrant

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

Groin node Lymph node metastasis Ultrasound therapy; complications Vulvar cancer stage I Vulvar cancer stage II

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Buderim Private Hospital

    Buderim, Queensland, 4556, Australia

  • John Hunter Hospital

    Newcastle, New South Wales, 2305, Australia

  • Mercy Hospital for Women

    Heidelberg, Victoria, 3084, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029, Australia

  • Royal Women's Hospital

    Parkville, Victoria, 3052, Australia

  • St Andrew's War Memorial Hospital

    Brisbane, Queensland, 4000, Australia

  • The Royal Darwin Hospital

    Darwin, Northern Territory, 0810, Australia

  • The Wesley Hospital

    Auchenflower, Queensland, 4066, Australia

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