Lymphedema, Perioperative/Postoperative Complications, Vulvar Cancer
Conditions
Keywords
lymphedema, perioperative/postoperative complications, stage I vulvar cancer, stage II vulvar cancer, stage III vulvar cancer, stage IVB vulvar cancer
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.
Interventions
DRUGfibrin sealant
PROCEDUREsurgical wound closure
Sponsors
National Cancer Institute (NCI)
Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively | — |
Countries
United States
Outcome results
None listed