Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
This study has been completed.
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00028951
First received: January 4, 2002
Last updated: September 2, 2012
Last verified: December 2005
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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 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) |
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
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Hide Study LocationsLocations
| 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: | September 2, 2012 |
| 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 IVB vulvar cancer |
Additional relevant MeSH terms:
|
Lymphedema Postoperative Complications Vulvar Neoplasms Lymphatic Diseases Pathologic Processes Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Vulvar Diseases Genital Diseases, Female Fibrin Tissue Adhesive Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013