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Home > "L" Clinical Trials Conditions > Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

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



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

For Condition: squamous cell carcinoma of the vulva,stage 1 vulvar cancer,stage 2 vulvar cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva. PURPOSE: Phase III trial to study the effectiveness of lymphatic mapping in treating patients with stage I or stage II cancer of the vulva.
Details: 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 and intraoperative 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CharlesLevenback,  Study Chair,  M.D. Anderson Cancer Center

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62794-9640
United States
Recruiting L.  Massad 217-545-8882

Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City,  Iowa,  52242-1002
United States
Recruiting Joel  Sorosky 319-356-2015

CCOP - Carle Cancer Center *Recruiting*
Urbana,  Illinois,  61801
United States
Recruiting Kendrith  Rowland 217-383-4083

Mayo Clinic Cancer Center *Recruiting*
Rochester,  Minnesota,  55905-0001
United States
Recruiting Harry  Long 507-284-4320

CCOP - Metro-Minnesota *Recruiting*
St. Louis Park,  Minnesota,  55416
United States
Recruiting Patrick  Flynn 952-993-15175

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0587
United States
Recruiting Edward  Hannigan 409-772-3368

Cancer Center at the University of Virginia *Recruiting*
Charlottesville,  Virginia,  22908
United States
Recruiting Willie  Andersen 434-924-9333

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill,  North Carolina,  27599-7295
United States
Recruiting Wesley  Fowler 919-966-1196

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4009
United States
Recruiting Charles  Levenback 713-745-2563

CCOP - Evanston *Recruiting*
Evanston,  Illinois,  60201
United States
Recruiting Gershon  Locker 847-570-2518

Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos,  California,  95032
United States
Recruiting Nick  Spirtos 408-866-3843

Saint Joseph Regional Medical Center *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Michael  Method 574-237-8010

Fred Hutchinson Cancer Research Center *Recruiting*
Seattle,  Washington,  98109-1024
United States
Recruiting Benjamin  Greer 206-685-2463

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44124
United States
Recruiting Peter  Rose 216-444-1712

Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey,  Pennsylvania,  17033-0850
United States
Recruiting George  Olt 717-531-8144

Keesler Medical Center - Keesler Air Force Base *Recruiting*
Keesler AFB,  Mississippi,  39534-2576
United States
Recruiting John  Bomalaski 228-377-6396

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

Cooper University Hospital *Recruiting*
Camden,  New Jersey,  08103-1489
United States
Recruiting David  Warshal 856-342-2185

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda,  Maryland,  20892-1182
United States
Recruiting Patient  Recruitment 1-888-NCI-1937

Tufts - New England Medical Center *Recruiting*
Boston,  Massachusetts,  02111
United States
Recruiting Kenneth  Noller 617-636-2382

Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia,  Missouri,  65203
United States
Recruiting Sara  Crowder 573-882-1057

Siteman Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting David  Mutch 314-362

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver,  Colorado,  80010
United States
Recruiting Francis  Major 303-388-4876

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0526
United States
Recruiting Nader  Husseinzadeh 513-558-8450

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha,  Nebraska,  68106
United States
Recruiting James  Mailliard 402-280-4364

Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City,  New York,  10021
United States
Recruiting Carol  Brown 212-639-7659

Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington,  Vermont,  05401
United States
Recruiting Cheung  Wong 802-847-5110

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

Norwegian Radium Hospital *Recruiting*
Oslo,  ,  N-0310
Norway
Recruiting Gunnar  Kristensen 47-22-934-000

University of Minnesota Cancer Center *Recruiting*
Minneapolis,  Minnesota,  55455
United States
Recruiting Linda  Carson 612-626-3347

CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville,  Pennsylvania,  17822-2001
United States
Recruiting Nava  Siegelmann-Danieli 570-271-6834

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Mack  Barnes 205-934-0930

University Cancer Center at University of Washington Medical Center *Recruiting*
Seattle,  Washington,  98195-6043
United States
Recruiting Benjamin  Greer 206-685-2463

H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa,  Florida,  33612-9497
United States
Recruiting James  Fiorica 813-972-8478

Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia,  Pennsylvania,  19104-4283
United States
Recruiting Mark  Morgan 215-662-6043

Duke Comprehensive Cancer Center *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Daniel  Clarke-Pearson 919-684-3765

Ireland Cancer Center *Recruiting*
Cleveland,  Ohio,  44106
United States
Recruiting Steven  Waggoner 216-844-5011

Abington Memorial Hospital *Recruiting*
Abington,  Pennsylvania,  19001-3788
United States
Recruiting Parviz  Hanjani 215-885-0220

Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville,  Tennessee,  37917
United States
Recruiting Kenneth  Cofer 865-673-9250

Indiana University Cancer Center *Recruiting*
Indianapolis,  Indiana,  46202-5289
United States
Recruiting Katherine  Look 317-274-8987

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Anthony  Evans 715-389-3101

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Magee-Womens Hospital *Recruiting*
Pittsburgh,  Pennsylvania,  15213-3180
United States
Recruiting Joseph  Kelley 412-641-5418

University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison,  Wisconsin,  53792-6188
United States
Recruiting Ellen  Hartenbach 608-263-1209

Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus,  Ohio,  43210-1240
United States
Recruiting Jeffrey  Fowler 614-293-8737

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Robert  Burger 714-456-7971

Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem,  North Carolina,  27157-1065
United States
Recruiting Brigitte  Miller 336-716-6673

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas,  Texas,  75390-9032
United States
Recruiting David  Miller 214-648-3026

CCOP - Kalamazoo *Recruiting*
Kalamazoo,  Michigan,  49007-3731
United States
Recruiting Raymond  Lord 269-373-7488

Roswell Park Cancer Institute *Recruiting*
Buffalo,  New York,  14263-0001
United States
Recruiting Shashikant  Lele 716-845-5776

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

CCOP - Christiana Care Health Services *Recruiting*
Newark,  Delaware,  19713
United States
Recruiting Stephen  Grubbs 302-623-4100

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville,  Tennessee,  37232-2516
United States
Recruiting Marta  Crispens 615-322-2114

University of Oklahoma College of Medicine *Recruiting*
Oklahoma City,  Oklahoma,  73190
United States
Recruiting Robert  Mannel 405-271-8787

Gynecologic Oncology Network *Recruiting*
Nashville,  Tennessee,  37203
United States
Recruiting Howard  Homesley 615-804-2216

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260


Additional Information:
Study ID Numbers:
  CDR0000066277;  GOG-173
Study Start Date: 
Record last reviewed: April 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003325

Other Squamous Cell Carcinoma Of The Vulva Studies:
1. Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

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

3. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

Related Studies:

Other squamous cell carcinoma of the vulva Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials

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

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  Other squamous cell carcinoma of the vulva Clinical Trials
  Other Washington Clinical Trials
  Other Seattle Clinical Trials


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