Spots Global Cancer Trial Database for Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
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Trial Identification
Brief Title: Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Official Title: GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
Study ID: NCT01500512
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Carilion Clinic Gynecological Oncology, Roanoke, Virginia, United States
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Contact Details
Name: Brian Slomovitz
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR
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