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

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Brief Title

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

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

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.
    

Detailed Description

      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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Lymphedema

Intervention

fibrin sealant


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug


Start Date

January 2003


Primary Completion Date

December 2005

Eligibility 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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jay W. Carlson, DO, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00028951

Organization ID

CDR0000069149

Secondary IDs

GOG-0195


Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Jay W. Carlson, DO, Study Chair, Gynecologic Oncology of West Michigan


Verification Date

December 2005