EUCTR2016-003973-16-NL进行中（未招募）1 期
Groningen International Study on Sentinel nodes in Vulvar cancer - III, a prospective phase 2 treatment trial - GROINSS-V III
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 157
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Histological confirmed primary SCC of the vulva
- •- T1 tumor, not encroaching urethra/vagina/anus
- •- Depth of invasion > 1mm
- •- Tumor diameter < 4cm
- •- Unifocal tumors
- •- No enlarged (>1.5cm) or suspicious inguinofemoral lymph nodes at imaging (CT/MRI/ultrasound)
- •- Possibility to obtain informed consent
- •- Metastatic sentinel lymph node; size of metastasis > 2mm
- •- Metastatic sentinel lymph node: more than 1 SN with metastasis = 2mm
- •- Patients are able to understand requirements of study, provide written informed consent and comply with the study and follow-up procedures
- •. Adequate bone marrow, renal and liver function:
- •Absolute neutrophil count = 1.5 x 109 /L
- •Platelet count = 100 x 109 /L
- •Creatinine clearance = 40 ml/min measured by the Cockroft Gault formula
- •Total bilirubin < 1.25 x ULN
- •Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 x ULN
- •- Performance status of 0, 1 or 2 on the Eastern Cooperative Oncology Group (ECOG) Scale
- •- Age 18 years or older
- •- Life expectancy of = 12 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 82
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •- Inoperable tumors and tumors > 4cm
- •- Multifocal tumors
- •- Tumors with other pathology than squamous cell carcinoma
- •- Patients with enlarged / suspicious lymph nodes which are proven metastatic after fine needle aspiration cytology
- •- No other carcinomas, other than basal cell carcinomas, within last 5 years
- •- History of pelvic radiotherapy
- •- History of any infection requiring hospitalization or antibiotics within 2 weeks before enrollment
- •- Pregnant female or nursing mother
- •- Known brain or spinal cord metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
- •- Unstable angina, myocardial infarction, cerebrovascular accident, > Class II congestive heart failure according to the New York Heart Association Classification for Congestive Heart Failure within 6 months before enrollment
研究者
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