Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With 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