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

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

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.

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.

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