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Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection (GROINSS-V)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01500512
Recruitment Status : Active, not recruiting
First Posted : December 28, 2011
Last Update Posted : August 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Stage I Vulvar Cancer Stage II Vulvar Cancer Stage III Vulvar Cancer Vulvar Squamous Cell Carcinoma Other: Clinical Observation

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.


Study Design

Study Type : Observational
Actual Enrollment : 148 participants
Official Title: GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
Actual Study Start Date : January 3, 2012
Primary Completion Date : July 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vulvar Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
Other: Clinical Observation
Undergo observation


Outcome Measures

Primary Outcome Measures :
  1. Safety of sentinel lymph node dissection [ Time Frame: Up to 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500512


  Hide Study Locations
Locations
United States, Arizona
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, United States, 85004
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Florida
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Kansas
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
United States, Michigan
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Lakeland Community Hospital
Niles, Michigan, United States, 49120
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Lakeland Hospital
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
United States, Minnesota
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Carolina
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, United States, 24016
Canada, Ontario
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Brian Slomovitz NRG Oncology
More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01500512     History of Changes
Other Study ID Numbers: GOG-0270
NCI-2012-00100 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000721346
GOG-0270 ( Other Identifier: NRG Oncology )
GOG-0270 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Vulvar Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Genital Diseases, Female