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

Status unconfirmed

Conditions studied: Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer, Vulvar Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01500512

Run by

Gynecologic Oncology Group

People needed

148

Starts

2012-01-03

Last updated by the study team

2021-09-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• University of Arizona Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Jackson Memorial Hospital-Holtz Children's Hospital — Miami, Florida, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• Sudarshan K Sharma MD Limted-Gynecologic Oncology — Hinsdale, Illinois, United States
• University of Kansas Cancer Center — Kansas City, Kansas, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Bronson Battle Creek — Battle Creek, Michigan, United States
• Mercy Health Saint Mary's — Grand Rapids, Michigan, United States
• Spectrum Health at Butterworth Campus — Grand Rapids, Michigan, United States
• Mercy Health Mercy Campus — Muskegon, Michigan, United States
• Lakeland Community Hospital — Niles, Michigan, United States
• Spectrum Health Reed City Hospital — Reed City, Michigan, United States
• Lakeland Hospital — Saint Joseph, Michigan, United States
• Marie Yeager Cancer Center — Saint Joseph, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
• Cancer Research for the Ozarks NCORP — Springfield, Missouri, United States
• CoxHealth South Hospital — Springfield, Missouri, United States
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Overlook Hospital — Summit, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.