Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gynecologic Oncology Group
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
