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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer
Female
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
Principal Investigator
Jay W. Carlson, DO
Investigator Role:
Study Chair
Investigator Affiliation:
Gynecologic Oncology of West Michigan
Authority:
United States: Federal Government
Study ID:
CDR0000069149
NCT ID:
NCT00028951
Start Date:
January 2003
Completion Date:
Related Keywords:
- Lymphedema
- Perioperative/Postoperative Complications
- Vulvar Cancer
- lymphedema
- perioperative/postoperative complications
- stage I vulvar cancer
- stage II vulvar cancer
- stage III vulvar cancer
- stage IVB vulvar cancer
- Lymphedema
- Postoperative Complications
- Vulvar Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| University of Oklahoma College of Medicine | Oklahoma City, Oklahoma 73190 |
| Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| CCOP - Central Illinois | Springfield, Illinois 62526 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Denver, Colorado 80010 |
| MBCCOP - University of Illinois at Chicago | Chicago, Illinois 60612 |
| CCOP - Evanston | Evanston, Illinois 60201 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| CCOP - Geisinger Clinic and Medical Center | Danville, Pennsylvania 17822-2001 |
| UPMC Cancer Center at Magee-Womens Hospital | Pittsburgh, Pennsylvania 15213-3180 |
| Southeast Gynecologic Oncology Associates | Knoxville, Tennessee 37917 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus | Burlington, Vermont 05401 |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Fox Chase-Temple Cancer Center | Philadelphia, Pennsylvania 19111-2442 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
