Feasibility Study Comparing Groin Ultrasound Surveillance With Surgical Node Dissection in Women With Early Stage Vulvar Cancer

What this Trial Is About

Researchers are evaluating a new approach for women with vulvar cancer, specifically those at Stage I or II, to reduce the significant side effects caused by current treatments. This trial aims to see if it is possible to safely replace surgical removal of groin lymph nodes with regular high-resolution ultrasound checks combined with clinical exams. This approach could lessen surgery-related harm while still monitoring cancer spread effectively. Participants are divided into groups one receives regular bilateral groin ultrasounds and clinical exams every two months for a year after primary tumor surgery, while the other undergoes standard upfront surgical groin lymph node removal or sentinel node biopsy based on current medical guidelines. A third group includes women with suspicious ultrasound findings who receive standard surgery immediately. Ultrasounds are reviewed by experts who quickly report any suspicious lymph nodes for further action. During the study, women will have frequent follow-up visits with clinical exams and ultrasounds, with specialists monitoring imaging results closely. The main goal is to measure how many women agree to be randomly assigned to either treatment method over 12 months. Additional research will explore whether tumor mutations and blood markers can help detect cancer spread over up to 15 years. The total involvement includes regular monitoring and assessments to ensure safety and feasibility of this less invasive strategy.

NODE (groiN ultrasOunD cancEr)