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

May 27, 2015 updated by: Gynecologic Oncology Group

Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Long Beach, California, United States, 90801
        • Todd Cancer Institute at Long Beach Memorial Medical Center
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
      • Hartford, Connecticut, United States, 06102-5037
        • Helen and Harry Gray Cancer Center at Hartford Hospital
      • New Britain, Connecticut, United States, 06050
        • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at Washington Hospital Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Georgia
      • Savannah, Georgia, United States, 31403-3089
        • Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
    • Illinois
      • Hinsdale, Illinois, United States, 60521
        • Hinsdale Hematology Oncology Associates
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Indianapolis Hospital
      • Indianapolis, Indiana, United States, 46237
        • Gynecologic Oncology of Indiana
      • Kokomo, Indiana, United States, 46904
        • Howard Community Hospital
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, United States, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, United States, 46617
        • South Bend Clinic
    • Iowa
      • Iowa City, Iowa, United States, 52242-1002
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center - Bramhall Campus
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts-NEMC Cancer Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
      • St. Joseph, Michigan, United States, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center at University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Springfield, Missouri, United States, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, United States, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Women's Cancer Center - Lake Mead
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Voorhees, New Jersey, United States, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Hope A Women's Cancer Center
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Winston-Salem, North Carolina, United States, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Canton, Ohio, United States, 44710-1799
        • Aultman Cancer Center at Aultman Hospital
      • Cincinnati, Ohio, United States, 45267
        • Charles M. Barrett Cancer Center at University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, United States, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
      • Mayfield Heights, Ohio, United States, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Mentor, Ohio, United States, 44060
        • Lake/University Ireland Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
      • Tulsa, Oklahoma, United States, 74136-1929
        • Cancer Care Associates - Saint Francis Campus
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Cancer Center at Magee-Womens Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Centers for Cancer Care
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Dallas, Texas, United States, 75235
        • UT Southwestern University Hospital - Zale Lipshy
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • LDS Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Carilion Gynecologic Oncology Associates
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Madison, Wisconsin, United States, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Waukesha, Wisconsin, United States, 53188
        • Waukesha Memorial Hospital Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Sentinenal lymph node mapping
Procedure: Sentinel lymph node mapping
Sentinel lymph node mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Predictive value of negative sentinel lymph nodes in vulvar cancer patients
Time Frame: at time of surgery
at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Charles Levenback, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Primary Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (ESTIMATE)

January 27, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0173
  • CDR0000066277 (OTHER: CDR)
  • NCI-2009-00579 (OTHER: NCI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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