Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
Trial status: Open for Enrollment
Why is this study being done?
- 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.
Who is eligible to participate?
- Patients with squamous cell carcinoma, depth of invasion > 1 mm
- Patients with T1 or T2 tumors (International Federation of Gynecology and Obstetrics [FIGO] staging), tumors < 4 cm, and/or not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
- Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
- Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes
- No inoperable tumors and tumors with diameter > 4 cm
- No patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm)/suspicious groin nodes, and with cytologically proven inguinofemoral lymph node metastases
- No patients with multifocal tumors
- Not specified
PRIOR CONCURRENT THERAPY:
- Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
- No concurrent intensity-modulated radiation therapy