Ultrasound surveillance for vulvar cancer treatment
Randomised Feasibility Study of Groin Ultrasound Surveillance to De-Escalate Surgical Intervention in Women With Vulvar Cancer
This study is testing if regular ultrasound check-ups can be a safer alternative to surgery for women with vulvar cancer to monitor lymph node involvement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Queensland Centre for Gynaecological Cancer Government |
| Drugs / interventions | radiation |
| Locations | 5 sites (Brisbane, Queensland and 4 other locations) |
| Trial ID | NCT06264167 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women over 18 with histologically confirmed vulvar cancer at Stage I or II, without evidence of metastatic disease.
Not a fit: Patients with non-invasive vulvar conditions or those with evidence of metastatic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive monitoring option for vulvar cancer patients, potentially reducing treatment-related morbidity.
How similar studies have performed: While the approach of using ultrasound surveillance is innovative, similar studies have shown promise in other cancer types, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Brisbane, Queensland and 4 other locations
- St Andrew's War Memorial Hospital — Brisbane, Queensland, Australia (Recruiting)
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
- The Wesley Hospital — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Buderim Private Hospital — Sunshine Coast, Queensland, Australia (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.