TP043/#1565 Phase II Activity Trial of High Dose Radiation and Chemosensitization in Patients with Macrometastatic Lymph Node Spread after Sentinel Node Biopsy in Vulvar Cancer: Groningen International Study on Sentinel Nodes in Vulvar Cancer III (GROINSS-V III/NRG-GY024)

Objectives To investigate the safety of replacing inguinofemoral lymphadenectomy (IFL) by chemoradiation in early-stage vulvar cancer patients with a macrometastasis (>2 mm) and/or extracapsular extension in the sentinel node (SN). Methods This is an international multicenter single-arm phase II prospective clinical trial. Primary endpoint is groin recurrence rate in the first two years after primary treatment. Secondary endpoints are short and long-term morbidity associated with the SN procedure and chemoradiation and quality of life as measured by EORTC-QLQc30. Patients with invasive (>1 mm) squamous cell carcinoma of the vulva, stage T1, tumor size <4 cm diameter and no suspicious lymph nodes by imaging will proceed with SN detection. Institutions enrolling patients must demonstrate prior surgical experience with the submission of at least 10 successfully completed SN cases in vulvar cancer. Patients with SN metastases > 2 mm and/or with extracapsular extension or those with >1 SN with micrometastases are eligible. Treatment consists of chemoradiation with a dose of 56 Gy to the groin combined with weekly cisplatin 40 mg/m2 IV on days 1, 8, 15, 21 and 29 of radiotherapy. One hundred and fifty-seven patients in Europe, United States and Canada will be enrolled. The study includes continuous monitoring of groin recurrences with stopping rules. Results of this trial may be practice changing and eliminate the need for IFL in all women with clinically early stage vulvar cancer. The study is currently open for enrollment. NCT05076942. Results Trial in progress: there are no available results/conclusions at the time of submission. Conclusions N/A