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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00028951
First received: January 4, 2002
Last updated: July 8, 2013
Last verified: December 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
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:


Further study details as provided by Gynecologic Oncology Group:

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: December 2005 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1740
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
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
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States, 60612
CCOP - Central Illinois
Decatur, Illinois, United States, 62794-9640
CCOP - Evanston
Evanston, Illinois, United States, 60201
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
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 - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905-0001
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
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
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11790-7775
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7570
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1065
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0520
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44124
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73104
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73190
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
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0587
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
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
Investigators
Study Chair: Jay W. Carlson, DO Gynecologic Oncology of West Michigan
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00028951     History of Changes
Other Study ID Numbers: CDR0000069149, GOG-0195, NCI-P01-0201
Study First Received: January 4, 2002
Last Updated: July 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
lymphedema
perioperative/postoperative complications
stage I vulvar cancer
stage II vulvar cancer
stage III vulvar cancer
stage IVB vulvar cancer

Additional relevant MeSH terms:
Lymphedema
Postoperative Complications
Vulvar Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Lymphatic Diseases
Neoplasms
Neoplasms by Site
Pathologic Processes
Urogenital Neoplasms
Vulvar Diseases
Fibrin Tissue Adhesive
Coagulants
Hematologic Agents
Hemostatics
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014