Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection

PRIMARY OBJECTIVES:

I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after
lymph node dissection to confirm the safety of this procedure.

OUTLINE:

Patients receive standard therapy including sentinel lymph node dissection. Patients are then
observed to collect information about treatment and outcomes every 2 months for 2 years.

Inclusion Criteria:

- Patients must have squamous cell carcinoma with a depth invasion > 1 mm

- Patients must have T1 or T2 tumors (International Federation of Gynecology and
Obstetrics[FIGO] staging), < 4 cm, not encroaching in urethra, vagina, or anus with
clinically negative inguinofemoral lymph nodes

- Localization and size of the tumor are such that peri-lesional injection of the
tracers at three or four sites is possible

- Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes

- Patients must sign informed consent

Exclusion Criteria:

- Inoperable tumors with diameter > 4 cm

- 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

- Patients with multifocal tumors

- Patients who are currently on an investigational drug for the treatment of vulvar
cancer are excluded from participation in this trial