Phase 3 study
Not yet recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| John Hunter Hospital | Newcastle | NSW | Status not stated |
| The Royal Darwin Hospital | Darwin | NT | Status not stated |
| The Wesley Hospital | Auchenflower | QLD | Status not stated |
| St Andrew's War Memorial Hospital | Brisbane | QLD | Status not stated |
| Royal Brisbane and Women's Hospital | Brisbane | QLD | Status not stated |
| Buderim Private Hospital | Buderim | QLD | Status not stated |
| Royal Adelaide Hospital | Adelaide | SA | Status not stated |
| Mercy Hospital for Women | Heidelberg | VIC | Status not stated |
| Royal Women's Hospital | Parkville | VIC | Status not stated |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
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
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 24 March 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.