Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gynecologic Oncology Group
Collaborator:
National Cancer Institute (NCI)
Treatments:
Fibrin Tissue Adhesive
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