Summary
Treatment for vulvar cancer can cause significant long-term side effects. Although vulvar cancer is rare, around 2,500 women in Australia are living with the lasting impacts of their treatment, with few options currently available to reduce these effects.
At present, women with early-stage (Stage I or II) vulvar cancer usually have surgery to remove lymph nodes in the goin (called a lymph node dissection or LND) to check if the cancer has spread. This surgery can cause ongoing pain, swelling, and mobility problems. A smaller operation called a sentinel node biopsy (SNB) can be done for some patients, but it is only suitable for about half of women and can still occasionally miss cancer cells.
Researchers believe that modern, high-resolution ultrasound scans could offer a safer alternative. Advances in ultrasound technology mean it may now be just as accurate as surgery in finding small signs of cancer spread, without the risks of major surgery and radiation.
The ANVU trial is testing whether using regular (serial) groin ultrasound scans can safely replace immediate groin surgery for women with Stage I or II vulvar cancer. If an ultrasound shows signs of cancer spread, only then would surgery be performed.
This study aims to find out if this approach can reduce treatment side effects and improve quality of life for women, while still keeping survival outcomes just as strong. It's an important step towards a less invasive and more patient-centred treatment option for women with early-stage vulvar cancer in Australia.
All participants will have surgery to remove the vulvar tumour and will receive a bilateral (both sides) groin ultraound up to 30 days before the planned surgery.
Participants with normal or negative baseline groin ultrasound results will be randomly assigned to one of two groups:
- Intervention group: will receive ultrasounds every 2 months and clinical examiniations every 3 months (groin lymph nodes are not removed).
- Standard group: will undergo upfront full LND or SNB based on clinician choice.
Participants with suspicious or intermediate baseline groin ultrasounds will receive standard treatment (LND or SNB).