Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
NCT ID: NCT00028951
Last Updated: 2013-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2003-01-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
Interventions
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fibrin sealant
surgical wound closure
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Jay W. Carlson, DO
Role: STUDY_CHAIR
Gynecologic Oncology of West Michigan
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States
CCOP - Christiana Care Health Services
Newark, Delaware, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Evanston
Evanston, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Saint Joseph Regional Medical Center
South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Southeast Gynecologic Oncology Associates
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
Burlington, Vermont, United States
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States
Countries
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References
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Carlson JW, Kauderer J, Walker JL, Gold MA, O'Malley D, Tuller E, Clarke-Pearson DL; Gynecologic Oncology Group. A randomized phase III trial of VH fibrin sealant to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jul;110(1):76-82. doi: 10.1016/j.ygyno.2008.03.005. Epub 2008 May 15.
Carlson J, Kauderer J, Walker J, et al.: Phase III trial of Tisseel to reduce lymphedema after inguinal lymph node dissection: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-228, 2007.
Other Identifiers
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GOG-0195
Identifier Type: -
Identifier Source: secondary_id
NCI-P01-0201
Identifier Type: -
Identifier Source: secondary_id
CDR0000069149
Identifier Type: -
Identifier Source: org_study_id
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