How women with gynaecological cancer are guiding a new clinical trial

The Queensland Centre for Gynaecological Cancer (QCGC) Research is on a mission to develop the best possible standard of care for women with gynaecological cancer. Since 2003, QCGC Research has been dedicated to finding kinder, gentler, and more effective treatments for women diagnosed with gynaecological cancer.

The QCGC Research team, led by Professor Andreas Obermair, is currently focused on starting a new clinical trial in vulvar cancer. Vulvar cancer is a rare gynaecological cancer, with around 400 women in Australia diagnosed every year. Standard treatment for vulvar cancer involves surgery to remove the primary tumour as well as groin lymph nodes. Surgical removal of groin lymph nodes is required to assess whether cancer has spread beyond the primary tumour, however, it can cause debilitating, long-term side effects including persistently painful and disfiguring lower limb swelling, impaired mobility and increased susceptibility to infections. Approximately 70% of women with early-stage vulvar cancer have their groin lymph nodes removed despite them being cancer-free. These women suffer unnecessarily from the side effects of their treatment.

The QCGC Research team first became aware of this issue when a woman who had been diagnosed with vulvar cancer and was being treated by Professor Obermair vehemently declined to have her groin lymph nodes removed due to anticipated morbidity. This prompted the QCGC Research team to conduct interviews with other women diagnosed with vulvar cancer to understand their concerns about treatment. A group of six consumers led the analysis and interpretation of interview transcripts, four of whom had lived experience of gynaecological cancer and two had cared for a loved one with gynaecological cancer.

Gynaecological cancer advocate and lived experience expert, Meredith Johnston, was delighted to be invited to join the consumer-led research group. With an established career as a laboratory technician in the tertiary sector, Meredith was aware of the critical role that research plays in advancing medical knowledge.

"I have worked in laboratories for many years, so I understand the immense value, importance, and potential that research holds," Meredith explained. "Contributing to this project as both a consumer with lived experience and a scientist allowed me to bring a unique perspective. It enhanced the breadth and depth of my contributions, enriching the overall research process. The experience became even more fulfilling when the manuscript we were working on was published.^[1]

Based on women’s concerns about the terrible and debilitating side effects of standard treatment for vulvar cancer, the QCGC Research team has developed a new clinical trial that aims to prevent the lifelong, detrimental side effects of standard treatment without compromising survival. This new trial, known as the Australian National VUlvar cancer (ANVU) trial, will test whether high-resolution ultrasound can identify whether vulvar cancer has spread to groin lymph nodes. Instead of all women having their groin lymph nodes surgically removed, only women in whom ultrasound identifies suspicious groin lymph nodes will have these removed. It is anticipated that this will spare approximately 70% of women with early-stage vulvar cancer from having their groin lymph nodes removed and prevent them from undergoing potentially devastating side effects.

The QCGC Research team has also partnered with consumer organisations, including Lymphoedema Association Australia and Cherish Women’s Cancer Foundation, to further develop ANVU trial planning and provide input into participant information materials and consent forms. The ANVU trial is expected to open in Queensland in mid-2025, other Australian States and Territories in late-2025, and internationally in 2026.