ANVU Trial

Please note, recruitment for the ANVU trial will commence in 2026.

Vulvar cancer is a rare disease, with approximately 400 women diagnosed in Australia and 45,000 women diagnosed worldwide every year.

Standard treatment of invasive vulvar cancer involves the surgical removal of the primary tumour plus surgical groin lymph node dissection. Whilst groin lymph node dissection is often curative, it is also associated with debilitating short- and long-term side effects.

Unfortunately, standard methods like physical examination and CT scans do not reliably detect the spread of cancer to the groin lymph nodes. As a result, current guidelines recommend that all women diagnosed with Stage IB or Stage II vulvar cancer receive groin lymph node dissection to mitigate the risk of missing groin node metastases. This can be delivered through a full inguinofemoral lymph node dissection (IFL) (removing as many nodes as possible) or through a sentinel node biopsy (SNB) (removing only one or two targeted groin lymph nodes). SNB is less invasive, but only suitable for smaller, single-site tumours (about half of Stage IB and Stage II cases) and carries a 10% risk of missing cancerous nodes.

In approximately 30% of cases, a groin lymph node dissection finds cancer in the nodes, leading to postoperative radiation treatment. Should positive groin nodes be missed and become enlarged, more than 90% of patients will die within 12 months despite subsequent treatment. However, if groin node involvement is detected early while still small, survival outcomes are expected to be excellent.

Advances in ultrasound technology now allow for accurate detection of groin lymph 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.

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

This trial offers a promising new way to reduce the heavy treatment burden faced by women with vulvar cancer, without sacrificing survival outcomes.

We are looking for new national and international sites for the ANVU trial.

If you are an investigator or researcher, and you would like to collaborate with us, please register your interest HERE