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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003325
First received: November 1, 1999
Last updated: August 16, 2012
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Vulvar Cancer
 Drug: isosulfan blue
Procedure: conventional surgery
Procedure: sentinel lymph node biopsy
 Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 630
Study Start Date: December 1999
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003325

  Show 72 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Charles Levenback, MD M.D. Anderson Cancer Center
Investigator: Benjamin E. Greer, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Levenback CF, Tian C, Coleman RL, et al.: Sentinel node (SN) biopsy in patients with vulvar cancer: A Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5505, 2009.

Responsible Party: Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003325     History of Changes
Other Study ID Numbers: CDR0000066277, GOG-173
Study First Received: November 1, 1999
Last Updated: August 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I vulvar cancer
stage II vulvar cancer
squamous cell carcinoma of the vulva

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Vulvar Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013