Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With … (NCT00028951) | Clinical Trial Compass
CompletedPhase 3
Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva
United StatesStarted 2003-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively