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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

NCT06476639 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2026-03-24

No results posted yet for this study

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.

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

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.

Sponsors & Collaborators

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • The University of Queensland

    collaborator OTHER

  • Queensland Centre for Gynaecological Cancer

    lead OTHER_GOV

Principal Investigators

  • Andreas Obermair, MD · Director, Queensland Centre for Gynaecological Cancer Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2035-12-31
Completion
2035-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06476639 on ClinicalTrials.gov