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: Randomized phase 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.

Condition	Treatment or Intervention	Phase
Lymphedema perioperative/postoperative complications stage I vulvar cancer stage II vulvar cancer stage III vulvar cancer stage IV vulvar cancer	Drug: fibrin sealant  Procedure: complications of therapy assessment/management  Procedure: supportive care/therapy  Procedure: surgical wound healing	Phase III

Further Study 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 time of drain removal, at week 6, and then at months 3 and 6.

Patients are followed at week 6 and at months 3 and 6.

PROJECTED ACCRUAL: A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange,  California,  92868,  United States; Recruiting
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1740,  United States; Recruiting
Colorado
      University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver,  Colorado,  80010,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
Indiana
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Iowa
      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1002,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905-0001,  United States; Recruiting
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Mississippi
      Keesler Medical Center - Keesler Air Force Base, Keesler AFB,  Mississippi,  39534-2576,  United States; Recruiting
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
New Jersey
      Cancer Institute of New Jersey at the Cooper University Hospital, Camden,  New Jersey,  08103-1489,  United States; Recruiting
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States; Recruiting
North Carolina
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1065,  United States; Recruiting
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States; Recruiting
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Charles M. Barrett Cancer Center at University Hospital, Cincinnati,  Ohio,  45267-0520,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73190,  United States; Recruiting
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001-3788,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Vermont
      Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington,  Vermont,  05401,  United States; Recruiting
Washington
      MultiCare Regional Cancer Center at Tacoma General Hospital, Tacoma,  Washington,  98405,  United States; Recruiting

Study chairs or principal investigators

Jay Carlson, DO, MC, LTC,  Study Chair,  Gynecologic Oncology of West Michigan   

Study ID Numbers:  CDR0000069149; GOG-0195; NCI-P01-0201; NCT00028951
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  January 4, 2002
ClinicalTrials.gov Identifier:  NCT00028951
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08