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

NCT00028951 | Completed Phase 3

• 3 other identifiers: CDR0000069149GOG-0195NCI-P01-0201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 49

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Secondary Outcomes (1)

• Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively

Interventions

fibrin sealant DRUG

surgical wound closure PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (49)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1740, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80010, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Location

MBCCOP - University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

CCOP - Central Illinois

Decatur, Illinois, 62794-9640, United States

Location

CCOP - Evanston

Evanston, Illinois, 60201, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint Joseph Regional Medical Center

South Bend, Indiana, 46617, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Kalamazoo

Kalamazoo, Michigan, 49007-3731, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905-0001, United States

Location

CCOP - Metro-Minnesota

Saint Louis Park, Minnesota, 55416, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler Air Force Base

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Ellis Fischel Cancer Center at University of Missouri - Columbia

Columbia, Missouri, 65203, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65807, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

Camden, New Jersey, 08103-1489, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Long Island Cancer Center at Stony Brook University Hospital

Stony Brook, New York, 11790-7775, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7570, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1065, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0520, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44124, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73104, United States

Location

Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73190, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001-3788, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Fox Chase-Temple Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213-3180, United States

Location

Southeast Gynecologic Oncology Associates

Knoxville, Tennessee, 37917, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-2516, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0587, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

Burlington, Vermont, 05401, United States

Location

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Related Publications (2)

• 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.

  PMID: 18482765 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lymphedema; Postoperative Complications; Vulvar Neoplasms

Interventions

Fibrin Tissue Adhesive; Wound Closure Techniques

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Surgical Procedures, Operative

Study Officials

• Jay W. Carlson, DO

  Gynecologic Oncology of West Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: January 4, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2003
• Primary Completion: December 1, 2005
• Last Updated: July 9, 2013

Record last verified: 2005-12

Locations

US (49)