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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

Conditions
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Vulvar Cancer

Intervention / Treatment
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* Procedure: Sentinel lymph node mapping


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sentinenal lymph node mapping<br>Sentinenal lymph node mapping | Procedure: Sentinel lymph node mapping<br>* Sentinel lymph node mapping<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value of negative sentinel lymph nodes in vulvar cancer patients |  | at time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I vulvar cancer, stage II vulvar cancer, squamous cell carcinoma of the vulva