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

Gynecologic Oncology Group (GOG)

Status: Unknown

Conditions: Stage III Vulvar Cancer; Vulvar Squamous Cell Carcinoma; Stage II Vulvar Cancer; Stage I Vulvar Cancer

Treatments: Other: Clinical Observation

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01500512

U10CA027469 (U.S. NIH Grant/Contract)

CDR0000721346

U10CA180868 (U.S. NIH Grant/Contract)

NCI-2012-00100 (Registry Identifier)

GOG-0270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

148 participants in 1 patient group

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.

Treatment:

Other: Clinical Observation