Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 72
- 主要终点
- Predictive value of negative sentinel lymph nodes in vulvar cancer patients
研究概览
简要总结
RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.
PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.
详细描述
OBJECTIVES:
- Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.
- Determine the location of the sentinel node in these patients.
OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence.
PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg
- •Tumor size must be 2-6 cm
- •No recurrent disease
- •Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed
- •No tumor extending into the urethra, anus, vagina, rectum, or bladder
- •No grossly suspicious or inflamed groin nodes on physical exam
- •No grossly infected primary tumors
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •No other invasive malignancy within the past 5 years except non-melanomatous skin cancer
- •No known hypersensitivity to phenylethane compounds
- •PRIOR CONCURRENT THERAPY:
- •No prior cancer therapy that contraindicates therapy in this study
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No prior groin dissection
排除标准
- 未提供
研究组 & 干预措施
Sentinenal lymph node mapping
Sentinenal lymph node mapping
干预措施: Sentinel lymph node mapping (Procedure)
结局指标
主要结局
Predictive value of negative sentinel lymph nodes in vulvar cancer patients
时间窗: at time of surgery
次要结局
未报告次要终点