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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
Not Enrolling
Female
Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer

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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 InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
CCOP - Scott and White HospitalTemple, Texas  76508
Fletcher Allen Health Care - Medical Center Hospital of Vermont CampusBurlington, Vermont  05401
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Fox Chase-Temple Cancer CenterPhiladelphia, Pennsylvania  19111-2442
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103