Australian National Vulvar Cancer Trial
NCT Number: NCT06476639
Acronym: ANVU
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Vulvar Cancer Stage I|Vulvar Cancer Stage II|Lymph Node Metastasis|Groin Node|Ultrasound Therapy; Complications
Interventions: DIAGNOSTIC_TEST: High-resolution bilateral groin ultrasound monitoring
Sponsor: Queensland Centre for Gynaecological Cancer
Collaborators: Royal Brisbane and Women's Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2025-04
Completion Date: 2029-04
Locations: John Hunter Hospital, Newcastle, New South Wales, 2305, Australia|The Royal North Shore Hospital, Sydney, New South Wales, 2065, Australia|The Royal Darwin Hospital, Darwin, Northern Territory, 0810, Australia|The Wesley Hospital, Auchenflower, Queensland, 4066, Australia|Mater Hospital, Brisbane, Queensland, 4000, Australia|St Andrew's War Memorial Hospital, Brisbane, Queensland, 4000, Australia|Royal Brisbane and Women's Hospital, Brisbane, Queensland, 4029, Australia|Buderim Private Hospital, Buderim, Queensland, 4556, Australia|Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia|Royal Hobart Hospital, Hobart, Tasmania, 7000, Australia|Mercy Hospital for Women, Heidelberg, Victoria, 3084, Australia|Royal Women's Hospital, Parkville, Victoria, 3052, Australia|St John of God Hospital, Subiaco, Western Australia, 6904, Australia

Summary:
This study is a phase II, 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.

Primary Outcome Measures: Incidence of enlarged clinically palpable groin nodes (groin metastases) in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND., Determine the incidence of palpable, fixed to skin and histologically positive groin nodes in women with vulvar cancer randomised to serial high-resolution groin ultrasound monitoring compared to standard upfront surgical groin LND., 12 months after surgery
Secondary Outcome Measures: Patient Reported Outcomes (PROMs), Compare PROMS between the groups, as measured by the EuroQoL-5D and FACT-V questionnaires, at baseline, 8 weeks, 6 months, and 12 months., 12 months after surgery|Health Related Quality of Life (HRQL), Compare HRQL between the groups, as measured by the EuroQoL-5D and FACT-V questionnaires at baseline, 8 weeks, 6 months and 12 months., 12 months after surgery|Pain, Compare pain levels between the groups, 12 months after surgery|Adverse events, Compare adverse events between the groups, 12 months after surgery|Lower limb lymphoedema, Compare the incidence of lower limb lymphoedema between the groups, 12 months after surgery|Cost-effectiveness, Compare cost effectiveness between the groups, 12 months after surgery|Disease-free survival, Compare disease-free survival between the groups, 12 months after surgery|Overall survival, Compare overall survival between the groups, 12 months after surgery|Clinical accuracy of high-resolution serial ultrasound to predict groin lymph node involvement, Determine the diagnostic accuracy of pre-operative, standardised, high-resolution groin ultrasound to identify groin node metastasis, 12 months after surgery|Utility of circulating tumour DNA to reliably reflect the presence or absence of positive groin lymph nodes, Assess the role of circulating tumour DNA to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance, Study duration of up to 15 years|Utility of plasma to reliably reflect the presence or absence of positive groin lymph nodes, Assess the role of plasma to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance, Study duration of up to 15 years|Utility of serum to reliably reflect the presence or absence of positive groin lymph nodes, Assess the role of serum to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance, Study duration of up to 15 years|Utility of tumour mutations to reliably reflect the presence or absence of positive groin lymph nodes, Assess the role of tumour mutations to accurately determine the burden of disease (positive lymph nodes) in vulvar cancer, assist with risk stratification and aid disease surveillance, Study duration of up to 15 years