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 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: ANVU
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 9

Brief 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

Lymph Node Metastasis; Groin Node; Ultrasound Therapy; Complications; Vulvar Cancer Stage I; Vulvar Cancer Stage II

Keywords

Vulvar Cancer; Ultrasound Therapy

Outcome Measures

Primary Outcomes (1)

• Survival following the development of groin node metastasis (GNS, Groin Node-related Survival) at 30 months.

  Determine survival following the development of groin node metastasis (GNS, Groin Node-related Survival) in patients with vulvar cancer randomised to serial high-resolution groin USM compared to standard upfront surgical groin LND at 30 months.

  30 months

Secondary Outcomes (10)

• Compare return to usual daily activities at 18 months between the groups

  18 months

• HRQL and PROMS as measured by the EQ-5D and FACT-V at baseline, 8 weeks, 6 months, 12 months, 18 months, 24 months, and 30 months.

  30 months

• Morbidity at 12 months after surgery.

  12 months

• Incidence of lower limb lymphoedema up to 30 months after surgery.

  30 months

• Cost and cost-effectiveness at 12 months post-surgery.

  12 months

Study Arms (3)

Participants with normal/negative baseline groin ultrasounds - Intervention Group

EXPERIMENTAL

Surgical removal of primary tumour and serial high-resolution bilateral groin ultrasound monitoring every 2 months for 12 months, and at month 15 and month 18, with clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 months (n=360).

Diagnostic Test: High-resolution bilateral groin ultrasound monitoring

Participants with normal/negative baseline groin ultrasounds - Standard Group

NO INTERVENTION

Surgical removal of primary tumour and upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=120).

Participants with suspicious/indeterminate baseline groin ultrasound - Standard Treatment

NO INTERVENTION

Participants with suspicious/indeterminate baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines (n=160).

Interventions

High-resolution bilateral groin ultrasound monitoring DIAGNOSTIC_TEST

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.

Participants with normal/negative baseline groin ultrasounds - Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva
• Clinically stage 1b or 2 on medical imaging (CT or MRI scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
• Willing and able to undergo IFL/SNB according to local clinical practice management guidelines
• Willing and able to comply with all study requirements, timing and/or nature of required assessments.
• Signed written informed consent
• Negative (serum or urine) pregnancy (BHCG) test ≤ 30 days of surgery ONLY in pre-menopausal women and women \< 2 years after the onset of menopause.

You may not qualify if:

• Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget's disease)
• Clinical or medical imaging evidence of regional and/or distant metastatic disease
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
• Estimated life expectancy of ≤6 months

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead
• Royal Brisbane and Women's Hospital: collaborator
• The University of Queensland: collaborator

Study Sites (9)

John Hunter Hospital

Newcastle, New South Wales, 2305, Australia

Location

The Royal Darwin Hospital

Darwin, Northern Territory, 0810, Australia

Location

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

St Andrew's War Memorial Hospital

Brisbane, Queensland, 4000, Australia

Location

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Buderim Private Hospital

Buderim, Queensland, 4556, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Mercy Hospital for Women

Heidelberg, Victoria, 3084, Australia

Location

Royal Women's Hospital

Parkville, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Vulvar Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Obermair, MD

  Director, Queensland Centre for Gynaecological Cancer Research

  STUDY CHAIR

Central Study Contacts

Brianna Armstrong

CONTACT

+61 7 3346 5063; anvutrial@uq.edu.au

Sara Baniahmadi

CONTACT

+61 7 3346 5073; anvutrial@uq.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A phase III, open label, multicentre, three-group, randomised clinical trial. 640 eligible females aged 18 or older with clinically stage 1b or 2 vulvar cancer will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery: Participants with normal/negative baseline groin ultrasounds will be randomly assigned to two groups (3:1 randomisation). The Intervention Group will receive serial bilateral groin node ultrasounds and clinical examinations for 18 months (groin lymph nodes are not removed). The Standard Group will undergo upfront full groin lymph node dissection (LND) or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines). Participants with abnormal baseline groin ultrasound (third group) will receive an upfront full groin LND or SNB, consistent with the current standard treatment, according to local clinical practice management guidelines.

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 26, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9)