Trial Information

Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study

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.