NODE (groiN ultrasOunD cancEr)
Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer
Queensland Centre for Gynaecological Cancer
30 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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)
Exclusion Criteria5
- 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
- Estimated life expectancy of ≤6 months
Interventions
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.
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT06264167