Summary

for females ages 18 years and up (full criteria)
at Orange, California and other locations
study started

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVES:

  1. 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.

Keywords

Stage I Vulvar CancerStage II Vulvar CancerStage III Vulvar CancerVulvar Squamous Cell CarcinomaCarcinoma, Squamous CellVulvar NeoplasmsClinical Observation

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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 CAN'T join 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

Locations

  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    OrangeCalifornia92868United States
  • Women's Cancer Center of Nevada
    Las VegasNevada89169United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Gynecologic Oncology Group
ID
NCT01500512
Study Type
Observational
Last Updated