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

Primary Purpose

Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
fibrin sealant
surgical wound closure
Sponsored by
Gynecologic Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphedema focused on measuring lymphedema, perioperative/postoperative complications, stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at University of Alabama at Birmingham
  • CCOP - Western Regional, Arizona
  • Jonsson Comprehensive Cancer Center at UCLA
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • CCOP - Christiana Care Health Services
  • Walter Reed Army Medical Center
  • MBCCOP - University of Illinois at Chicago
  • CCOP - Central Illinois
  • CCOP - Evanston
  • CCOP - Carle Cancer Center
  • Saint Joseph Regional Medical Center
  • Holden Comprehensive Cancer Center at University of Iowa
  • CCOP - Michigan Cancer Research Consortium
  • CCOP - Grand Rapids
  • CCOP - Kalamazoo
  • University of Minnesota Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • University of Mississippi Medical Center
  • Keesler Medical Center - Keesler Air Force Base
  • Ellis Fischel Cancer Center at University of Missouri - Columbia
  • CCOP - Kansas City
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Missouri Valley Cancer Consortium
  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Long Island Cancer Center at Stony Brook University Hospital
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  • Duke Comprehensive Cancer Center
  • Comprehensive Cancer Center at Wake Forest University
  • Charles M. Barrett Cancer Center at University Hospital
  • Cleveland Clinic Taussig Cancer Center
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • University of Oklahoma College of Medicine
  • Oklahoma University Medical Center
  • CCOP - Columbia River Oncology Program
  • Abington Memorial Hospital
  • CCOP - Geisinger Clinic and Medical Center
  • Fox Chase-Temple Cancer Center
  • UPMC Cancer Center at Magee-Womens Hospital
  • Southeast Gynecologic Oncology Associates
  • Vanderbilt-Ingram Cancer Center
  • University of Texas Medical Branch
  • M.D. Anderson Cancer Center at University of Texas
  • CCOP - Scott and White Hospital
  • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
  • MultiCare Regional Cancer Center at Tacoma General Hospital

Outcomes

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

Full Information

First Posted
January 4, 2002
Last Updated
July 8, 2013
Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00028951
Brief Title
Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer
Keywords
lymphedema, perioperative/postoperative complications, stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fibrin sealant
Intervention Type
Procedure
Intervention Name(s)
surgical wound closure
Primary Outcome Measure Information:
Title
Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Secondary Outcome Measure Information:
Title
Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jay W. Carlson, DO
Organizational Affiliation
Gynecologic Oncology of West Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1740
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62794-9640
Country
United States
Facility Name
CCOP - Evanston
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Keesler Medical Center - Keesler Air Force Base
City
Keesler AFB
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Ellis Fischel Cancer Center at University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103-1489
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Long Island Cancer Center at Stony Brook University Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790-7775
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7570
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1065
Country
United States
Facility Name
Charles M. Barrett Cancer Center at University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0520
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States
Facility Name
University of Oklahoma College of Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oklahoma University Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001-3788
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Fox Chase-Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Cancer Center at Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-3180
Country
United States
Facility Name
Southeast Gynecologic Oncology Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2516
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0587
Country
United States
Facility Name
M.D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
MultiCare Regional Cancer Center at Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18482765
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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