Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
Phase 3
N/A
N/A
N/A
N/A
Not Enrolling
Female
Vulvar Cancer
Female
Vulvar Cancer
Trial Information
Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Disease status
Safety Issue:
No
Principal Investigator
Charles Levenback, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066277
NCT ID:
NCT00003325
Start Date:
December 1999
Completion Date:
Related Keywords:
- Vulvar Cancer
- stage I vulvar cancer
- stage II vulvar cancer
- squamous cell carcinoma of the vulva
- Vulvar Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
| Hinsdale Hematology Oncology Associates | Hinsdale, Illinois 60521 |
| Tufts-NEMC Cancer Center | Boston, Massachusetts 02111 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
| Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
| St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Gundersen Lutheran Center for Cancer and Blood | La Crosse, Wisconsin 54601 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Todd Cancer Institute at Long Beach Memorial Medical Center | Long Beach, California 90801 |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
| Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Gynecologic Oncology of Indiana | Indianapolis, Indiana 46237 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| South Bend Clinic | South Bend, Indiana 46617 |
| Maine Medical Center - Bramhall Campus | Portland, Maine 04102 |
| Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Women's Cancer Center - Lake Mead | Las Vegas, Nevada 89102 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
| Hope A Women's Cancer Center | Asheville, North Carolina 28801 |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| Baptist Centers for Cancer Care | Memphis, Tennessee 38120 |
| Parkland Memorial Hospital | Dallas, Texas 75235 |
| UT Southwestern University Hospital - Zale Lipshy | Dallas, Texas 75235 |
