Groningen International Study on Sentinel Nodes in Vulvar Cancer-III
Trial Parameters
Brief Summary
Vulvar cancer patients with SN-metastasis \> 2mm will receive chemoradiation instead of an inguinofemoral lymphadenectomy.
Eligibility Criteria
Inclusion Criteria: * Histological confirmed primary SCC of the vulva * T1 tumor, not encroaching urethra/vagina/anus * Depth of invasion \> 1mm * Tumor diameter \< 4cm * Unifocal tumor * No enlarged (\>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound) * Possibility to obtain informed consent * Metastatic sentinel lymph node; size of metastasis \> 2mm and / or extracapsular extension, or * Metastatic sentinel lymph node: more than 1 SN with metastasis ≤ 2mm * Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures * Adequate bone marrow, renal and liver function: * Absolute neutrophil count ≥ 1.5 x 109 /L * Platelet count ≥ 100 x 109 /L * Creatinine clearance ≥ 40 ml/min measured by the Cockroft Gault formula * Total bilirubin \< 1.25 x ULN Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN * Performance status of 0, 1 or 2 on the Eastern Cooperative Onco