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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00003325
First received: November 1, 1999
Last updated: May 27, 2015
Last verified: May 2015
  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
Procedure: Sentinel lymph node mapping
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Predictive value of negative sentinel lymph nodes in vulvar cancer patients [ Time Frame: at time of surgery ] [ Designated as safety issue: No ]

Enrollment: 515
Study Start Date: December 1999
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sentinenal lymph node mapping
Sentinenal lymph node mapping
Procedure: Sentinel lymph node mapping
Sentinel lymph node mapping

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 72 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Charles Levenback, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003325     History of Changes
Other Study ID Numbers: GOG-0173, CDR0000066277, NCI-2009-00579
Study First Received: November 1, 1999
Last Updated: May 27, 2015
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage I vulvar cancer
stage II vulvar cancer
squamous cell carcinoma of the vulva

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

ClinicalTrials.gov processed this record on August 27, 2015