Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
NCT ID: NCT01500512
Last Updated: 2021-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
148 participants
OBSERVATIONAL
2012-01-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Groups
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Observation (observe patients undergoing SLN dissection)
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.
Clinical Observation
Undergo observation
Interventions
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Clinical Observation
Undergo observation
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Brian Slomovitz
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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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
Countries
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Other Identifiers
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NCI-2012-00100
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000721346
Identifier Type: -
Identifier Source: secondary_id
GOG-0270
Identifier Type: -
Identifier Source: secondary_id
GOG-0270
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0270
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0270
Identifier Type: -
Identifier Source: org_study_id
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