NCT00028951已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 97
- 主要终点
- Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status:
- •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
- •Bilirubin no greater than 1.5 times normal
- •SGOT no greater than 3 times normal
- •Albumin at least 3.0 g/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No prior lower extremity deep vein thrombosis
- •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
- •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
- •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
排除标准
- 未提供
结局指标
主要结局
Incidence of lymphedema of the lower extremity at 1 week, 6 weeks, 3 months, and 6 months postoperatively
次要结局
- Frequency of surgical complications at 1 week, 6 weeks, 3 months, and 6 months postoperatively
研究者
研究点 (97)
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