Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-30 @ 1:14 PM
Study NCT ID:
NCT00028951
Status:
COMPLETED
Last Update Posted:
2013-07-09
First Post:
2002-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D014846', 'term': 'Vulvar Neoplasms'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D058106', 'term': 'Wound Closure Techniques'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-12', 'lastUpdateSubmitDate': '2013-07-08', 'studyFirstSubmitDate': '2002-01-04', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively'}]}, 'conditionsModule': {'keywords': ['lymphedema', 'perioperative/postoperative complications', 'stage I vulvar cancer', 'stage II vulvar cancer', 'stage III vulvar cancer', 'stage IVB vulvar cancer'], 'conditions': ['Lymphedema', 'Perioperative/Postoperative Complications', 'Vulvar Cancer']}, 'referencesModule': {'references': [{'pmid': '18482765', 'type': 'RESULT', '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."}, {'type': '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."}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Compare the frequency of surgical complications in patients treated with fibrin sealant vs standard care.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: After radical vulvectomy or hemivulvectomy and lymphadenectomy, patients receive fibrin sealant to surgical site.\n* Arm II: After surgery, patients receive standard care for closure of surgical site.\n\nLymphedema is assessed at time of drain removal, at week 6, and then at months 3 and 6.\n\nPatients are followed at week 6 and at months 3 and 6.\n\nPROJECTED ACCRUAL: A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of vulvar malignancy\n\n * Stage I-IVB\n* Planned radical vulvectomy or hemivulvectomy AND\n* Ipsilateral or bilateral inguinal lymphadenectomy\n* Presence of groin node metastases is allowed\n* No primary or secondary lymphedema of the lower extremities\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* GOG 0-3\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Platelet count at least 100,000/mm\\^3\n* Absolute neutrophil count at least 1,500/mm\\^3\n* No bleeding disorder\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* SGOT no greater than 3 times normal\n* Albumin at least 3.0 g/dL\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n\nCardiovascular:\n\n* No prior lower extremity deep vein thrombosis\n\nOther:\n\n* No known sensitivity or anaphylaxis to bovine-derived products\n* No known prior exposure to fibrin tissue adhesive\n* No other malignancy within the past 5 years except nonmelanoma skin cancer\n* No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis\n* No prior fracture of any portion of either leg\n* Preoperative circumferential measurements of legs must differ by less than 3 cm\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy for a prior malignancy\n* Concurrent adjuvant chemotherapy allowed\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy for a prior malignancy\n* No prior radiotherapy to pelvis, abdomen, inguinal area, or lower extremity\n\nSurgery:\n\n* See Disease Characteristics\n* No prior inguinal surgery\n* No prior surgery to veins or arteries of either leg\n* No other concurrent elective surgery during same operative event as inguinal lymphadenectomy\n\nOther:\n\n* At least 30 days since prior investigational products or devices\n* At least 7 days since prior anticoagulants\n* Concurrent enrollment on GOG-0173 or other adjuvant treatment protocols is allowed\n* No other concurrent investigational products or devices'}, 'identificationModule': {'nctId': 'NCT00028951', 'briefTitle': 'Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva', 'organization': {'class': 'NETWORK', 'fullName': 'GOG Foundation'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CDR0000069149'}, 'secondaryIdInfos': [{'id': 'GOG-0195'}, {'id': 'NCI-P01-0201'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'fibrin sealant', 'type': 'DRUG'}, {'name': 'surgical wound closure', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006-2726', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CCOP - Western Regional, Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095-1740', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80010', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center at University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19713', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '20307-5001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'MBCCOP - 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Carlson, DO', 'role': 'STUDY_CHAIR', 'affiliation': 'Gynecologic Oncology of West Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}