• Disease status [ Designated as safety issue: No ]
• Tumor characteristics (e.g., stage, clinical tumor size, status of the capillary/lymphatic spaces, and histologic type of tumor) [ Designated as safety issue: No ]
• Host characteristics (e.g., age and performance status) [ Designated as safety issue: No ]
• Adverse effects of the mapping procedure and dissection (i.e., frequency and severity) [ Designated as safety issue: Yes ]

• 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)

RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.

PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.

OBJECTIVES:

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

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.

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

• Drug: isosulfan blue
• Procedure: conventional surgery
• Procedure: sentinel lymph node biopsy

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

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

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