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



Status:Active, not recruiting
Conditions:Cervical Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/25/2017
Start Date:January 3, 2012

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

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
38
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Chapel Hill, North Carolina 27599
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Grand Rapids, Michigan 49503
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Greenville, South Carolina 29605
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Houston, Texas 77030
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Houston, Texas 77030
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Kansas City, Kansas 66160
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3131 La Canada St # 241
Las Vegas, Nevada 89169
(702) 693-6870
Women's Cancer Center of Nevada The Women's Cancer Center is a recognized leader in the...
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Minneapolis, Minnesota 55455
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Morristown, New Jersey 07962
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Muskegon, Michigan 49444
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Niles, Michigan 49120
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Pittsburgh, Pennsylvania 15232
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Providence, Rhode Island 02905
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300 N Patterson Rd
Reed City, Michigan 49677
(231) 832-3271
Spectrum Health Reed City Hospital At Spectrum Health Reed City Hospital, you have access to...
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Roanoke, Virginia 24016
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Saint Joseph, Michigan 49085
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3900 Hollywood Road
Saint Joseph, Michigan 49085
(269) 428-4411
Marie Yeager Cancer Center The Marie Yeager Cancer Center is located at the Lakeland Health...
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759 Chestnut Street
Springfield, Massachusetts 01199
(413) 794 - 0000
Baystate Medical Center Baystate Medical Center (BMC), in Springfield, Massachusetts, is an academic, research, and...
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3801 South National Avenue
Springfield, Missouri 65807
(417) 269-6000
CoxHealth South Hospital U.S. News & World Report has ranked CoxHealth one of Missouri's best...
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Springfield, Missouri 65804
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99 Beauvoir Avenue
Summit, New Jersey 07902
(908) 522-2000
Overlook Hospital Atlantic Health System
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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