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

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00028951

Purpose

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	Intervention	Phase
Lymphedema Perioperative/Postoperative Complications Vulvar Cancer	Drug: fibrin sealant Procedure: surgical wound closure	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
Official Title:	A Phase III Clinical Trial Use of TISSEEL VH Fibrin Sealant to Reduce Lymphedema Incidence After Inguinal Lymph Node Dissection Performed in the Management of Vulvar Malignancies

Resource links provided by NLM:

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Cancer Lymphedema Surgery Vulvar Cancer

Drug Information available for: Beriplast Fibrin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Secondary Outcome Measures:

Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Study Start Date:	January 2003
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028951

Hide Study Locations

Locations

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

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Jay W. Carlson, DO

Gynecologic Oncology of West Michigan

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Carlson JW, Kauderer J, Walker JL, Gold MA, O'Malley D, Tuller E, Clarke-Pearson DL. 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 May 13; [Epub ahead of print]

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.

Study ID Numbers:	CDR0000069149, GOG-0195, NCI-P01-0201
Study First Received:	January 4, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00028951 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

lymphedema
perioperative/postoperative complications
stage I vulvar cancer

stage II vulvar cancer
stage III vulvar cancer
stage IV vulvar cancer

Additional relevant MeSH terms:

Coagulants
Fibrin Tissue Adhesive
Hematologic Agents
Genital Neoplasms, Female
Urogenital Neoplasms
Pharmacologic Actions
Hemostatics
Lymphedema
Genital Diseases, Female

Lymphatic Diseases
Neoplasms
Pathologic Processes
Neoplasms by Site
Postoperative Complications
Vulvar Neoplasms
Therapeutic Uses
Vulvar Diseases

ClinicalTrials.gov processed this record on November 22, 2009