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

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

• Registration Number: NCT01500512
• Lead Sponsor: Gynecologic Oncology Group

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 Timeline

• Study First Submitted: 2011-12-24
• Study First Submitted QC: 2011-12-24
• Study First Posted: 2011-12-28
• Study Start: 2012-01-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-09-30
• Primary Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of sentinel lymph node dissection	Up to 2 years

Trial Locations

Locations (37)

University of Arizona Cancer Center at Saint Joseph's; 🇺🇸 Phoenix, Arizona, United States

Saint Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center; 🇺🇸 Orange, California, United States

Jackson Memorial Hospital-Holtz Children's Hospital; 🇺🇸 Miami, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States

Sudarshan K Sharma MD Limted-Gynecologic Oncology; 🇺🇸 Hinsdale, Illinois, United States

University of Kansas Cancer Center; 🇺🇸 Kansas City, Kansas, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Bronson Battle Creek; 🇺🇸 Battle Creek, Michigan, United States

Mercy Health Saint Mary's; 🇺🇸 Grand Rapids, Michigan, United States

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