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A Phase III Randomised Clinical Trial of Ultrasound Groin Monitoring Versus Groin Lymph Node Dissection to De-Escalate the Extent of Surgery in Vulvar Cancer
Sponsor: Queensland Centre for Gynaecological Cancer
Summary
This study is a phase III, open label, multicentre, three-group, randomised clinical trial. The primary aim of this study is to determine whether intensive groin ultrasound monitoring (1) is effective and safe to replace invasive groin lymph node dissection (LND) to manage vulvar cancer, (2) decreases the morbidity associated with vulvar cancer surgery, and (3) is cost effective.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2026-06-01
Completion Date
2035-12-31
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
High-resolution bilateral groin ultrasound monitoring
Participants in the Interventional Group will undergo surgical excision of the primary tumour, either via radical local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months for 12 months, and at month 15 and month 18, and a clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 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 within 5 business days. If positive nodes are detected, participants will consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with serial ultrasounds and clinical exams based on preference and clinician guidance.
Locations (9)
John Hunter Hospital
Newcastle, New South Wales, Australia
The Royal Darwin Hospital
Darwin, Northern Territory, Australia
The Wesley Hospital
Auchenflower, Queensland, Australia
St Andrew's War Memorial Hospital
Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Buderim Private Hospital
Buderim, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Mercy Hospital for Women
Heidelberg, Victoria, Australia
Royal Women's Hospital
Parkville, Victoria, Australia