Clinical Trials

OBJECTIVES:

       -  To investigate the safety of replacing complete inguinofemoral lymphadenectomy by adjuvant radiotherapy in early-stage vulvar cancer patients with a sentinel node metastasis ≤ 2 mm.

       -  To evaluate the short- and long-term morbidity associated with the sentinel lymph node procedure and adjuvant (chemo)radiotherapy.

       -  To further establish the safety of omitting complete inguinofemoral lymphadenectomy in patients with a negative sentinel node.

       -  To explore the efficacy, safety, and short- and long-term morbidity of inguinofemoral lymphadenectomy and radiotherapy in patients with sentinel node metastasis > 2 mm. (exploratory)

     OUTLINE: This is a multicenter study.

     Patients undergo planned radical vulvectomy and sentinel lymph node dissection. Patients without lymph node involvement undergo observation. Patients with minimal lymph node involvement undergo radiotherapy. Patients with significant lymph node involvement undergo inguinofemoral lymphadenectomy and radiotherapy with or without chemotherapy according to institutional guidelines.

     After completion of study treatment, patients are followed up every 2 months for 2 years. Follow-up includes interview, gynecological examination, and palpation of the groins.