Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection (NCT01500512) | Clinical Trial Compass
UnknownNot Applicable
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
United States148 participantsStarted 2012-01-03
Plain-language summary
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.
Who can participate
Age range18 Years
SexFEMALE
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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