Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
- Conditions
- Stage II Vulvar CancerStage III Vulvar CancerVulvar Squamous Cell CarcinomaStage I Vulvar Cancer
- Interventions
- Other: Clinical Observation
- Registration Number
- NCT01500512
- Lead Sponsor
- Gynecologic Oncology Group
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 148
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observation (observe patients undergoing SLN dissection) Clinical Observation 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.
- Primary Outcome Measures
Name Time Method Safety of sentinel lymph node dissection Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
University of Arizona Cancer Center at Saint Joseph's
🇺🇸Phoenix, Arizona, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States
Cancer Research for the Ozarks NCORP
🇺🇸Springfield, Missouri, United States
CoxHealth South Hospital
🇺🇸Springfield, Missouri, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Marie Yeager Cancer Center
🇺🇸Saint Joseph, Michigan, United States
Carilion Clinic Gynecological Oncology
🇺🇸Roanoke, Virginia, 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
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
🇺🇸Hinsdale, Illinois, United States
Bronson Battle Creek
🇺🇸Battle Creek, Michigan, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Lakeland Community Hospital
🇺🇸Niles, Michigan, United States
Mercy Health Mercy Campus
🇺🇸Muskegon, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Lakeland Hospital
🇺🇸Saint Joseph, Michigan, United States
Spectrum Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
University of Minnesota/Masonic Cancer Center
🇺🇸Minneapolis, Minnesota, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Overlook Hospital
🇺🇸Summit, New Jersey, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute (UPCI)
🇺🇸Pittsburgh, Pennsylvania, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Saint Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States