Know Cancer

or
forgot password

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


Phase 3
N/A
N/A
Not Enrolling
Female
Vulvar Cancer

Thank you

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 CenterNew York, New York  10021
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Tufts-NEMC Cancer CenterBoston, Massachusetts  02111
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Avera Cancer InstituteSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Memorial Hospital of South BendSouth Bend, Indiana  46601
LDS HospitalSalt Lake City, Utah  84143
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Todd Cancer Institute at Long Beach Memorial Medical CenterLong Beach, California  90801
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Elkhart General HospitalElkhart, Indiana  46515
Gynecologic Oncology of IndianaIndianapolis, Indiana  46237
Howard Community HospitalKokomo, Indiana  46904
South Bend ClinicSouth Bend, Indiana  46617
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Women's Cancer Center - Lake MeadLas Vegas, Nevada  89102
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Baptist Centers for Cancer CareMemphis, Tennessee  38120
Parkland Memorial HospitalDallas, Texas  75235
UT Southwestern University Hospital - Zale LipshyDallas, Texas  75235