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

Phase 3
Not Enrolling
Vulvar Cancer

Thank you

Trial Information

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


- 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

Inclusion Criteria


- 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

- 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



- Any age

Performance status:

- GOG 0-3

Life expectancy:

- Not specified


- Not specified


- Not specified


- Not specified


- No other invasive malignancy within the past 5 years except non-melanomatous skin

- No known hypersensitivity to phenylethane compounds


- No prior cancer therapy that contraindicates therapy in this study

Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- Not specified


- Not specified


- See Disease Characteristics

- No prior groin dissection

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Disease status

Safety Issue:


Principal Investigator

Charles Levenback, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 1999

Completion Date:

Related Keywords:

  • Vulvar Cancer
  • stage I vulvar cancer
  • stage II vulvar cancer
  • squamous cell carcinoma of the vulva
  • Vulvar Neoplasms



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