ANVU Trial

RECRUITMENT HAS NOT YET COMMENCED

Vulvar cancer treatment often causes serious long-term side effects. Although it's a rare disease, over 2,500 women in Australia have survived it. Most of them continue to suffer from lasting impacts of their treatment, with no current options to reduce these effects. This creates a major personal and societal burden, making it a national health priority.

Standard methods like physical exams and CT scans are not reliable for detecting cancer spread to groin lymph nodes. As a result, guidelines recommend surgery for women diagnosed with Stage I or II vulvar cancer. This involves either removing all groin nodes (full LND) or just a few key ones (sentinel node biopsy or SNB). SNB is less invasive but only suitable for smaller, single-site tumors (about half of Stage I and II cases). It also carries a 10% risk of missing cancerous nodes.

In about 25% of cases (around 80 women in Australia each year), surgery finds cancer in the groin nodes, leading to radiation treatment. If these nodes are missed and grow larger, more than 90% of affected women die within a year, even with treatment. However, if caught early—while still small—survival rates are very high. Advances in ultrasound technology now allow for accurate detection of groin node involvement. Ultrasound is more precise than MRI, CT, or PET scans, doesn’t use harmful radiation, and is widely available—even outside major cities.

Researchers aim to reduce the need for invasive surgery by using regular high-resolution ultrasound scans to monitor groin nodes. Surgery would only be needed if cancer is detected early through ultrasound. The ANVU trial will test whether this approach is safe and effective for women with Stage I and II vulvar cancer.

This trial offers a promising new way to reduce the heavy treatment burden faced by Australian women with vulvar cancer—providing a less invasive option without sacrificing survival outcomes.

Register your interest here in collaborating with us.  After you register you will recevie a link to access the trial protocol and documentation.