Clinical Trial

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

Study acronym: ANVU
Not Yet Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-06-23; most recent amendment 2026-03-19.
Trial Details
NCT Number NCT06476639
Lead Sponsor Queensland Centre for Gynaecological Cancer
Collaborators: Royal Brisbane and Women's Hospital, The University of Queensland
Conditions Vulvar Cancer Stage I, Vulvar Cancer Stage II, Lymph Node Metastasis, Groin Node, Ultrasound Therapy; Complications
Enrollment 640 participants
Start Date 2026-06-01
Primary Completion 2035-12-31 (estimated)
Study Completion 2035-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-24