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
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