NCT00003325

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

Official Title:

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

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Vulvar Cancer

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Sentinel lymph node mapping
    • Description: Sentinel lymph node mapping
    • Arm Group Labels: Sentinenal lymph node mapping
Sponsor
  • Gynecologic Oncology Group