NODE

The NODE study is a randomised feasibility trial comparing groin ultrasound surveillance with groin node surgery in Queensland women with vulvar cancer, aiming to reduce the extent of surgery for this condition.

Vulvar cancer is a rare disease, affecting around 400 women in Australia each year, and develops from the skin of the vulva. It can spread locally to nearby structures (such as the vagina, urethra, and anus) or through lymphatic channels to the lymph nodes in the groin. Lymph nodes are a key part of the immune system, filtering harmful substances, including cancer cells, from the body and helping fight infections.

Despite being a rare cancer, at least 2500 survivors of vulvar cancer live in Australia.

The standard treatment for vulvar cancer involves surgery to remove the primary tumour and, if needed, the groin lymph nodes—a procedure known as lymph node dissection. This can either be a full dissection, where all the groin nodes are removed, or a sentinel node biopsy (SNB), where only one or two selected nodes are removed.

Most survivors live with the detrimental, life-long impacts resulting from their cancer treatment because there are currently no alternatives to mitigate these impacts.

While lymph node dissection can be effective, it also has significant short- and long-term complications. These include infections, blood buildup (hematoma), fluid buildup (seroma), pain, swelling (edema), and reduced mobility. A more serious complication is lymphedema, where the legs, genitals, and surrounding areas experience chronic swelling. Some patients may also suffer from persistent pain, nerve damage, or difficulty performing everyday activities. The aim is to recruit 30 patients over the next two years.

Trial Sites

Recruitment

The NODE trial opened for recruitment in July 2024.

The study aims to recruit 30 participants from Queensland sites. 4 participants have been enrolled to date.