Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic, Treatment	Closed	Any age	NCI	GOG-173 GOG-0173, NCT00003325

Objectives

1. Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.
2. Determine the location of the sentinel node in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg
  • Tumor size must be 2-6 cm
  • No recurrent disease



• Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed



• No tumor extending into the urethra, anus, vagina, rectum, or bladder



• No grossly suspicious or inflamed groin nodes on physical exam



• No grossly infected primary tumors

Prior/Concurrent Therapy:

• No prior cancer therapy that contraindicates therapy in this study

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No prior groin dissection

Patient Characteristics:

Age:

• Any age

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other invasive malignancy within the past 5 years except non-melanomatous skin cancer
• No known hypersensitivity to phenylethane compounds

Expected Enrollment

A total of 40-630 patients will be accrued for this study within 2-6 years.

Outcomes

Disease status
Tumor characteristics (e.g., stage, clinical tumor size, status of the capillary/lymphatic spaces, and histologic type of tumor)
Host characteristics (e.g., age and performance status)
Adverse effects of the mapping procedure and dissection (i.e., frequency and severity)

Outline

Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence.

Levenback CF, Tian C, Coleman RL, et al.: Sentinel node (SN) biopsy in patients with vulvar cancer: A Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5505, 2009.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Charles Levenback, MD, Protocol chair		Ph: 713-745-2563; 800-392-1611 Email: clevenba@mdanderson.org
Benjamin Greer, MD, Protocol co-chair		Ph: 206-685-2463

Registry Information
Official Title		Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
Trial Start Date		1999-12-16
Trial Completion Date		2001-11-15 (estimated)
Registered in ClinicalTrials.gov		NCT00003325
Date Submitted to PDQ		1998-05-06
Information Last Verified		2009-01-16
NCI Grant/Contract Number		CA27469

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