Brief Title
Observation in Patients With Early-Stage Vulvar Cancer Undergoing Sentinel Lymph Node Dissection
Official Title
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
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.
Study Type
Observational
Primary Outcome
Safety of sentinel lymph node dissection
Condition
Stage I Vulvar Cancer
Intervention
Clinical Observation
Study Arms / Comparison Groups
Observation (observe patients undergoing SLN dissection)
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
148
Start Date
January 3, 2012
Primary Completion Date
July 1, 2022
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Brian Slomovitz, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01500512
Organization ID
GOG-0270
Secondary IDs
NCI-2012-00100
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Brian Slomovitz, Principal Investigator, NRG Oncology
Verification Date
September 2021