Clinical Research Directory

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 Oncology Group (ECOG) Scale (Appendix A) * Age 18 years or older * Life expectancy of ≥ 12 weeks * Written informed consent Exclusion Criteria: * Inoperable tumors and tumors \> 4cm * Multifocal tumors * Tumors with other pathology than squamous cell carcinoma * Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology * No other carcinomas, other than basal cell carcinomas, within last 5 years * History of pelvic radiotherapy * History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment * Pregnant female or nursing mother * Desire to become pregnant * Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids * Unstable angina, myocardial infarction, cerebrovascular accident, \> Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure (see Appendix B) within 6 months before enrollment