Ultrasound surveillance for vulvar cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the feasibility of randomizing women with vulvar cancer into two treatment groups: one receiving surgical groin node dissection and the other undergoing high-resolution bilateral groin ultrasound surveillance every two months. The study addresses the significant morbidity associated with current treatment methods and seeks to provide a less invasive alternative for monitoring lymph node involvement. By comparing these two approaches, the trial hopes to identify a method that reduces the burden of treatment while effectively managing cancer progression.

Why it matters

Who can join: the full rules

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 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 Criteria:

* 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

Where it's running

• St Andrew's War Memorial Hospital
  Brisbane, Queensland, Australia Recruiting
• Royal Brisbane and Women's Hospital
  Brisbane, Queensland, Australia Recruiting
• Buderim Private Hospital
  Sunshine Coast, Queensland, Australia Recruiting
• The Wesley Hospital
  Brisbane, Queensland, Australia Not yet recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Not yet recruiting

Study contacts

• Study coordinator: Sara Baniahmadi
• Email: s.baniahmadi@uq.edu.au
• Phone: 07 3346 5073

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.