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Completed

NCT Number: NCT00003325

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

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.

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Key information

Conditions

Vulvar Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sentinel lymph node mapping

Procedure

Sentinel lymph node mapping

Primary outcomes

  1. Predictive value of negative sentinel lymph nodes in vulvar cancer patients

    Time frame: at time of surgery

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2013
First posted
Jan 27, 2003
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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