NODE (groiN ultrasOunD cancEr)
Recruiting
N/A
Interventional Study
Vulvar Cancer Stage Ib
Vulvar Cancer Stage II
Lymph Node Metastasis
Groin Node
Ultrasound Therapy; Complications
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 30 (estimated)
- Sponsor
- Queensland Centre for Gynaecological Cancer · Government
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About This Trial
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 ultr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 IF…
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