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.
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.
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
The University of Queensland
Collaborator