Australian National Vulvar Cancer Trial

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

April 30, 2025

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2029

Conditions
Vulvar Cancer Stage IVulvar Cancer Stage IILymph Node MetastasisGroin NodeUltrasound Therapy; Complications
Interventions
DIAGNOSTIC_TEST

High-resolution bilateral groin ultrasound monitoring

Participants in the Interventional Group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months and a clinical examination every 3 months, for a follow up period of 12 months. Senior imaging specialists review bilateral ultrasound scans for positive lymph nodes or suspicious findings, promptly sending reports to the primary care physician and trial manager if detected within 3 business days. Subsequently, participants consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with bi-monthly ultrasounds based on preference and clinician guidance.

Trial Locations (13)

2065

The Royal North Shore Hospital, Sydney

2305

John Hunter Hospital, Newcastle

3052

Royal Women's Hospital, Parkville

3084

Mercy Hospital for Women, Heidelberg

4000

Mater Hospital, Brisbane

St Andrew's War Memorial Hospital, Brisbane

4029

Royal Brisbane and Women's Hospital, Brisbane

4066

The Wesley Hospital, Auchenflower

4556

Buderim Private Hospital, Buderim

5000

Royal Adelaide Hospital, Adelaide

6904

St John of God Hospital, Subiaco

7000

Royal Hobart Hospital, Hobart

0810

The Royal Darwin Hospital, Darwin

All Listed Sponsors
collaborator

Royal Brisbane and Women's Hospital

OTHER_GOV

lead

Queensland Centre for Gynaecological Cancer

OTHER_GOV