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

Vulvar Squamous Cell Carcinoma Clinical Trial

— GROINSS-V  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01500512
• Other study ID #: GOG-0270
• Secondary ID: NCI-2012-00100CD
• Status: Active, not recruiting
• Start date: January 3, 2012

Study information

• Verified date: September 2021
• Source: GOG Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stage I Vulvar Cancer
• Stage II Vulvar Cancer
• Stage III Vulvar Cancer
• Vulvar Neoplasms
• Vulvar Squamous Cell Carcinoma

Intervention

Other:
• Clinical Observation
Undergo observation

Locations

Country	Name	City	State
Canada	Odette Cancer Centre- Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	Bronson Battle Creek	Battle Creek	Michigan
United States	Roswell Park Cancer Institute	Buffalo	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	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Mercy Health Saint Mary's	Grand Rapids	Michigan
United States	Spectrum Health at Butterworth Campus	Grand Rapids	Michigan
United States	Greenville Health System Cancer Institute-Faris	Greenville	South Carolina
United States	Sudarshan K Sharma MD Limted-Gynecologic Oncology	Hinsdale	Illinois
United States	M D Anderson Cancer Center	Houston	Texas
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	Women's Cancer Center of Nevada	Las Vegas	Nevada
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	University of Minnesota/Masonic Cancer Center	Minneapolis	Minnesota
United States	Morristown Medical Center	Morristown	New Jersey
United States	Mercy Health Mercy Campus	Muskegon	Michigan
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Lakeland Community Hospital	Niles	Michigan
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	Saint Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of Arizona Cancer Center at Saint Joseph's	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute (UPCI)	Pittsburgh	Pennsylvania
United States	Women and Infants Hospital	Providence	Rhode Island
United States	Spectrum Health Reed City Hospital	Reed City	Michigan
United States	Carilion Clinic Gynecological Oncology	Roanoke	Virginia
United States	Lakeland Hospital	Saint Joseph	Michigan
United States	Marie Yeager Cancer Center	Saint Joseph	Michigan
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Cancer Research for the Ozarks NCORP	Springfield	Missouri
United States	CoxHealth South Hospital	Springfield	Missouri
United States	Overlook Hospital	Summit	New Jersey
United States	Munson Medical Center	Traverse City	Michigan
United States	Oklahoma Cancer Specialists and Research Institute-Tulsa	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of sentinel lymph node dissection		Up to 2 years