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.
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
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)
Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ
Parallel
High-resolution bilateral groin ultrasound surveillance
Diagnostic testParticipants 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.
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.
Utility of tumour mutations to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of tumour mutations between positive and negative lymph nodes.
Utility of circulating tumour DNA to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of circulating tumour DNA between positive and negative lymph nodes.
Utility of plasma to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of plasma between positive and negative lymph nodes.
Utility of serum to determine positive lymph node metastasis.
Translational research - Compare the molecular profile of serum between positive and negative lymph nodes.
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Queensland Centre for Gynaecological Cancer
Lead sponsor
Royal Brisbane and Women's Hospital
Collaborator
St Andrew's War Memorial Hospital
Collaborator
Buderim Private Hospital
Collaborator
