NODE (groiN ultrasOunD cancEr)

NCT06264167 | Recruiting DMC

• 1 other identifier: NODE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

This study is an open label, prospective, experimental, randomised clinical trial. The primary aim of this study is to determine whether it is feasible to randomise vulvar cancer patients into one of two treatment arms:1) surgical groin node dissection (as delivered though either a sentinel node biopsy or inguinofemoral lymph node dissection (IFL), or 2) serial high-resolution bilateral groin ultrasound surveillance and clinical examination every 2 months for 12 months.

Conditions

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

Keywords

Vulvar Cancer; Ultrasound Therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility of randomisation: The percentage of patients willing to be randomised to either surgical groin node dissection or serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examination every 2 months.

  The feasibility of randomisation into (1) LND (IFL vs SNB) or (2) high-resolution bilateral groin ultrasound surveillance every 2 months will be determined through a practical sample size of n=20. Feasibility is declared if 30% of eligible patients (n=6 or more) can be randomised.

  12 months

Secondary Outcomes (4)

• Utility of tumour mutations to determine positive lymph node metastasis.

  Study duration up to 15 years

• Utility of circulating tumour DNA to determine positive lymph node metastasis.

  Study duration up to 15 years

• Utility of plasma to determine positive lymph node metastasis.

  Study duration up to 15 years

• Utility of serum to determine positive lymph node metastasis.

  Study duration up to 15 years

Study Arms (3)

Participants with normal/negative baseline groin ultrasounds

EXPERIMENTAL

Interventional Treatment: serial high-resolution bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months (n=13).

Diagnostic Test: High-resolution bilateral groin ultrasound surveillance

Participants with normal/negative baseline groin ultrasounds - Standard Care

NO INTERVENTION

Standard Treatment: receive upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines) (n=7).

Participants with suspicious/indeterminate baseline groin ultrasound

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=10).

Interventions

High-resolution bilateral groin ultrasound surveillance DIAGNOSTIC_TEST

Participants in the Interventional Treatment (serial ultrasounds) group will undergo surgical excision of the primary tumor, either via radical wide local excision or radical vulvectomy. Post-vulvar surgery, follow-up appointments occur bi-monthly for 12 months, involving a clinical examination and groin ultrasound. 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 if detected within 3 business days. Subsequently, participants consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with bi-monthly ultrasounds based on preference and clinician guidance.

Participants with normal/negative baseline groin ultrasounds

Eligibility Criteria

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

You may qualify if:

• Women, over 18 years, with histologically confirmed SCC or adenocarcinoma of the vulva
• Clinically stage I or II on medical imaging (CT scan of pelvis, abdomen, and chest), without evidence of regional or distant metastatic disease
• Participant must be suitable to undergo IFL/SNB according to local clinical practice management guidelines
• Signed written informed consent
• Negative serum pregnancy test ≤ 30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause
• Patient lives within 40 km of a medical diagnostic imaging centre (site investigator approval required for special circumstances)

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
• St Andrew's War Memorial Hospital: collaborator
• Buderim Private Hospital: collaborator

Study Sites (5)

St Andrew's War Memorial Hospital

Brisbane, Queensland, 4000, Australia

RECRUITING

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

RECRUITING

The Wesley Hospital

Brisbane, Queensland, 4066, Australia

NOT YET RECRUITING

Buderim Private Hospital

Sunshine Coast, Queensland, 4556, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

NOT YET RECRUITING

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

Central Study Contacts

Sara Baniahmadi

CONTACT

07 3346 5073; s.baniahmadi@uq.edu.au

Brianna Armstrong

CONTACT

07 3346 5063; bri.armstrong@uq.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Feasibility trial, open label, three-group, randomised clinical trial 30 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 (2:1 randomisation): one group undergoing radical procedures (groin lymph nodes are not removed) with bilateral groin ultrasound surveillance in conjunction with clinical examinations every 2 months, and the other group undergoing upfront full groin LND or sentinel node biopsy (SNB) based on clinician choice (according to local clinical practice management guidelines). 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.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 16, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5)