Stage I Vulvar CancerGROINSS-VNCT01500512
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
An observational study of Stage I Vulvar Cancer and Stage II Vulvar Cancer, run by Gynecologic Oncology Group at 37 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer
- What is being tested?
- Clinical Observation
- How many people
- 148 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 3 Jan 2012to 1 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States36 sites
Bronson Battle Creek
Battle Creek, Michigan, 49017
Roswell Park Cancer Institute
Buffalo, New York, 14263
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, 60521
M D Anderson Cancer Center
Houston, Texas, 77030
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89169
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, 33136
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455
Morristown Medical Center
Morristown, New Jersey, 07960
Mercy Health Mercy Campus
Muskegon, Michigan, 49444
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Lakeland Community Hospital
Niles, Michigan, 49120
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
University of Arizona Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232
Women and Infants Hospital
Providence, Rhode Island, 02905
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
Carilion Clinic Gynecological Oncology
Roanoke, Virginia, 24016
Lakeland Hospital
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Baystate Medical Center
Springfield, Massachusetts, 01199
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804
CoxHealth South Hospital
Springfield, Missouri, 65807
Overlook Hospital
Summit, New Jersey, 07902
Munson Medical Center
Traverse City, Michigan, 49684
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146
Canada1 site
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer, Vulvar Squamous Cell Carcinoma
- Being tested
- Clinical Observation
- Medical subject headings
- Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical ObservationOther
Undergo observation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Clinical Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of sentinel lymph node dissection
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study start3 Jan 2012
- Primary completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Vulvar CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brian Slomovitz, Principal investigator, NRG Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500512
- Sponsor's protocol ID
- GOG-0270
- Other IDs
- NCI-2012-00100, CDR0000721346, GOG-0270, GOG-0270, GOG-0270, U10CA180868, U10CA027469
- Acronym
- GROINSS-V
- Status last verified
- Sep 2021
- First submitted
- 24 Dec 2011
- Last updated
- 30 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
- ClinicalTrials.gov ID
- NCT01500512
- Acronym / sponsor ID
- GROINSS-V / GOG-0270
- Conditions
- Stage I Vulvar Cancer, Stage II Vulvar Cancer, Stage III Vulvar Cancer, Vulvar Squamous Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jan 2012 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation (observe patients undergoing SLN dissection) | – | Other: Clinical ObservationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical ObservationUndergo observation | Other | Observation (observe patients undergoing SLN dissection) |
Primary outcome
Safety of sentinel lymph node dissection
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Slomovitz principal investigator
NRG Oncology
37 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage I Vulvar Cancer and Stage II Vulvar Cancer, run by Gynecologic Oncology Group at 37 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of sentinel lymph node dissection (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.