NCT01500512Unknown不适用
GROningen INternational Study on Sentinel Nodes in Vulvar Cancer (GROINSS-V) II: An Observational Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 148
- 试验地点
- 37
- 主要终点
- Safety of sentinel lymph node dissection
研究概览
简要总结
This research trial studies patients with early-stage vulvar cancer undergoing sentinel lymph node dissection. Sentinel lymph node dissection may have fewer side effects than removing all lymph nodes. Observing patients undergoing sentinel lymph node dissection may help doctors confirm the safety of the procedure.
详细描述
PRIMARY OBJECTIVES:
I. To prospectively observe patients who receive radiation +/- chemotherapy immediately after lymph node dissection to confirm the safety of this procedure.
OUTLINE:
Patients receive standard therapy including sentinel lymph node dissection. Patients are then observed to collect information about treatment and outcomes every 2 months for 2 years.
研究设计
- 研究类型
- Observational
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
- •Patients must have squamous cell carcinoma with a depth invasion > 1 mm
- •Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics[FIGO] staging), < 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
- •Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible
- •Preoperative imaging do not show enlarged (< 1.5 cm) suspicious nodes
- •Patients must sign informed consent
排除标准
- •Inoperable tumors with diameter > 4 cm
- •Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases
- •Patients with multifocal tumors
- •Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
结局指标
主要结局
Safety of sentinel lymph node dissection
时间窗: Up to 2 years
次要结局
未报告次要终点
研究者
研究点 (37)
Loading locations...
相似试验
已完成
不适用
Lymph Node Mapping in Patients With Endometrial CancerEndometrial CancerNCT01818739Ohio State University Comprehensive Cancer Center204
Unknown
不适用
Tracers for Endometrial Cancer Sentinel Node LabelingEndometrial CancerSentinel Lymph NodeNCT04665544University Medical Centre Maribor83
已完成
3 期
Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.NCT02598219Centre Oscar Lambret262
终止
不适用
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing SurgeryStage I Endometrial CarcinomaStage II Endometrial CarcinomaStage III Endometrial CarcinomaStage IV Endometrial CarcinomaNCT01939028Case Comprehensive Cancer Center58
已完成
不适用
Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-DyeSentinel Lymph NodeMetastasisColorectal CancerNCT02122523Amsterdam UMC, location VUmc25