search
Back to results

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

Primary Purpose

Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer

Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
Clinical Observation
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Stage I Vulvar Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona Cancer Center at Saint Joseph's
  • Saint Joseph's Hospital and Medical Center
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • Jackson Memorial Hospital-Holtz Children's Hospital
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Sudarshan K Sharma MD Limted-Gynecologic Oncology
  • University of Kansas Cancer Center
  • Baystate Medical Center
  • Bronson Battle Creek
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Mercy Health Mercy Campus
  • Lakeland Community Hospital
  • Spectrum Health Reed City Hospital
  • Lakeland Hospital
  • Marie Yeager Cancer Center
  • Munson Medical Center
  • University of Minnesota/Masonic Cancer Center
  • Cancer Research for the Ozarks NCORP
  • CoxHealth South Hospital
  • Women's Cancer Center of Nevada
  • Morristown Medical Center
  • Overlook Hospital
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • UNC Lineberger Comprehensive Cancer Center
  • Ohio State University Comprehensive Cancer Center
  • Riverside Methodist Hospital
  • University of Oklahoma Health Sciences Center
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • University of Pittsburgh Cancer Institute (UPCI)
  • Women and Infants Hospital
  • Greenville Health System Cancer Institute-Faris
  • UT Southwestern/Simmons Cancer Center-Dallas
  • M D Anderson Cancer Center
  • Carilion Clinic Gynecological Oncology
  • Odette Cancer Centre- Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Arm Label

Observation (observe patients undergoing SLN dissection)

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety of sentinel lymph node dissection

Secondary Outcome Measures

Full Information

First Posted
December 24, 2011
Last Updated
September 28, 2021
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT01500512
Brief Title
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Acronym
GROINSS-V
Official Title
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
Study Type
Observational

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2012 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer, Vulvar Squamous Cell Carcinoma

7. Study Design

Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Observation (observe patients undergoing SLN dissection)
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Clinical Observation
Intervention Description
Undergo observation
Primary Outcome Measure Information:
Title
Safety of sentinel lymph node dissection
Time Frame
Up to 2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Slomovitz
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona Cancer Center at Saint Joseph's
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Saint Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Jackson Memorial Hospital-Holtz Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sudarshan K Sharma MD Limted-Gynecologic Oncology
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mercy Health Mercy Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Lakeland Community Hospital
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
Lakeland Hospital
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Marie Yeager Cancer Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Cancer Research for the Ozarks NCORP
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Women's Cancer Center of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Greenville Health System Cancer Institute-Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Carilion Clinic Gynecological Oncology
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Facility Name
Odette Cancer Centre- Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs