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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01500512

Acronym

GROINSS-V

Enrollment

148

Registered

2011-12-28

Start date

2012-01-03

Completion date

Unknown

Last updated

2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III Vulvar Cancer, Stage II Vulvar Cancer, Stage I Vulvar Cancer, Vulvar Squamous Cell Carcinoma

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.

Interventions

OTHERClinical Observation

Undergo observation

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Safety of sentinel lymph node dissection	Up to 2 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026