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Home > "F" Clinical Trials Conditions > Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva



Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

For Condition: perioperative/postoperative complications,stage 1 vulvar cancer,stage 3 vulvar cancer,Lymphedema,stage 2 vulvar cancer,stage 4 vulvar cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Fibrin sealant may decrease lymphedema following surgery to remove lymph nodes in the groin by helping to seal the lymphatic vessels. It is not yet known if fibrin sealant is effective in decreasing lymphedema following surgery to remove lymph nodes. PURPOSE: Randomizedphase III trial to determine the effectiveness of fibrin sealant in reducing lymphedema following surgical removal of lymph nodes in patients who have cancer of the vulva.
Details: OBJECTIVES: - Compare the incidence of lymphedema of the lower extremity after lymph node dissection in patients with vulvar malignancies treated with fibrin sealant vs standard care. - Compare the frequency of surgical complications in patients treated with fibrin sealant vs standard care. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: After radical vulvectomy or hemivulvectomy and lymphadenectomy, patients receive fibrin sealant to surgical site. - Arm II: After surgery, patients receive standard care for closure of surgical site. Lymphedema is assessed at weeks 1 and 6 and months 3 and 6. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of vulvar malignancy - Stage I-IVB - Planned radical vulvectomy or hemivulvectomy AND - Ipsilateral or bilateral inguinal lymphadenectomy - Presence of groin node metastases is allowed - No primary or secondary lymphedema of the lower extremities PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - GOG 0-3 Life expectancy: - Not specified Hematopoietic: - Platelet count at least 100,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - No bleeding disorder Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT no greater than 3 times normal - Albumin at least 3.0 g/dL Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No prior lower extremity deep vein thrombosis Other: - No known sensitivity or anaphylaxis to bovine-derived products - No known prior exposure to fibrin tissue adhesive - No other malignancy within the past 5 years except nonmelanoma skin cancer - No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis - No prior fracture of any portion of either leg - Preoperative circumferential measurements of legs must differ by less than 3 cm - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for a prior malignancy - Concurrent adjuvant chemotherapy allowed Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy for a prior malignancy - No prior radiotherapy to pelvis, abdomen, inguinal area, or lower extremity Surgery: - See Disease Characteristics - No prior inguinal surgery - No prior surgery to veins or arteries of either leg - No other concurrent elective surgery during same operative event as inguinal lymphadenectomy Other: - At least 30 days since prior investigational products or devices - At least 7 days since prior anticoagulants - Concurrent enrollment on GOG-0173 or other adjuvant treatment protocols is allowed - No other concurrent investigational products or devices
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JayCarlson,  Study Chair,  Walter Reed Army Institute of Research (WRAIR)

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

North Shore University Hospital *Recruiting*
Manhasset,  New York,  11030
United States
Recruiting Andrew  Menzin 516-562-4438

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

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

Yale Comprehensive Cancer Center *Recruiting*
New Haven,  Connecticut,  06520-8028
United States
Recruiting Peter  Schwartz 203-785-4014

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

Australia New Zealand Gynaecological Oncology Trials Group *Recruiting*
Camperdown,  New South Wales,  1450
Australia
Recruiting Michael  Friedlander 61-2-9562-1450

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

State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook,  New York,  11794
United States
Recruiting Michael  Pearl 631-444-2774

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

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

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

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

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia,  Pennsylvania,  19107-5541
United States
Recruiting Stephanie  King 215-762-2640

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

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

University of Chicago Cancer Research Center *Recruiting*
Chicago,  Illinois,  60637-1470
United States
Recruiting S.  Yamada 773-702-6722

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Gunter  Deppe 313-745-7286

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

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

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

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

Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook,  New York,  11790-7775
United States
Recruiting Michael  Pearl 631-444-2774

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

Tacoma General Hospital *Recruiting*
Tacoma,  Washington,  98405
United States
Recruiting Roger  Lee 253-403-1029

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

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

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

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

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

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

Fox Chase Cancer Center *Recruiting*
Philadelphia,  Pennsylvania,  19111
United States
Recruiting Michael  Bookman 215-728-2987

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

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73190
United States
Recruiting Joan  Walker 405-271-8707

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

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

Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago,  Illinois,  60612-3824
United States
Recruiting Howard  Strassner 312-942-6723

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

University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester,  Massachusetts,  01605-2982
United States
Recruiting Susan  Zweizig 508-334-1160

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

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

Walter Reed Army Medical Center *Recruiting*
Washington D.C.,  District of Columbia,  20307-5001
United States
Recruiting G.  Rose 202-782-8515

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

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

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

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Frederick  Ueland 606-257-1613

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

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

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

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

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

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

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

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

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

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

Tom Baker Cancer Center - Calgary *Recruiting*
Calgary,  Alberta,  T2N 4N2
Canada
Recruiting Gavin  Stuart 403-944-1721

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

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

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

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

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1740
United States
Recruiting Jonathan  Berek 310-206-5161

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

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

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

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

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

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

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

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

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

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

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

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

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

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


Additional Information:
Study ID Numbers:
  CDR0000069149;  GOG-0195,NCI-P01-0201
Study Start Date: 
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028951

Other Perioperative/postoperative Complications Studies:
1. Radiation Therapy With or Without Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Cancer of the Vulva

2. Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

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

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Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

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