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
Parallel
High-resolution bilateral groin ultrasound monitoring
Diagnostic testParticipants in the Interventional Group will undergo surgical excision of the primary tumour, either via radical local excision or radical vulvectomy. Post-vulvar surgery, participants will receive a groin node ultrasound every 2 months for 12 months, and at month 15 and month 18, and a clinical examination at 8 weeks, 4 months, 8 months, 12 months, 15 months, and 18 months. 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 within 5 business days. If positive nodes are detected, participants will consult their primary care physician for options. Depending on clinical judgment, they may be referred for LND or continue with serial ultrasounds and clinical exams based on preference and clinician guidance.
Survival following the development of groin node metastasis (GNS, Groin Node-related Survival) at 30 months.
Determine survival following the development of groin node metastasis (GNS, Groin Node-related Survival) in patients with vulvar cancer randomised to serial high-resolution groin USM compared to standard upfront surgical groin LND at 30 months.
Compare return to usual daily activities at 18 months between the groups
Return to usual daily activities at 18 months measured using the PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
HRQL and PROMS as measured by the EQ-5D and FACT-V at baseline, 8 weeks, 6 months, 12 months, 18 months, 24 months, and 30 months.
Compare Patient Reported Outcomes (PROMs) and Health Related Quality of Life (HRQL) between the groups.
Morbidity at 12 months after surgery.
Compare pain and adverse events (AEs) (morbidity) between the groups.
Incidence of lower limb lymphoedema up to 30 months after surgery.
Compare the incidence of lower limb lymphoedema at 30 months post-surgery between the groups.
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Queensland Centre for Gynaecological Cancer
Lead sponsor
Royal Brisbane and Women's Hospital
Collaborator
The University of Queensland
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
