NCT02434107已完成不适用
Controlled and Prospective Randomised Study to Compare Complete Lymph Node Dissection Versus Watchful Waiting in Patients With Malignant Melanoma With a Tumour Thickness of 1,0mm+ and Evidence of Metastases in the Sentinel Node
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 82
- 主要终点
- Distant metastases free survival
研究概览
简要总结
Sentinel lymph node biopsy (SLNB) is considered as standard diagnostic procedure in melanoma patients carrying a reasonable risk for metastases. In numerous studies the prognostic role of micro metastases in the sentinel node (SN) was described. However, the prognostic value of a complete lymph node dissection in patients with a positive SN is still unclear.
This study was planned to analyse the survival outcome of patients with a positive SN receiving complete lymphadenectomy versus watchful waiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cutaneous melanoma with a tumour thickness of at least 1,00mm
- •Positive sentinel node with micro metastases of max. 2mm in diameter
排除标准
- •Mucosal or ocular melanoma
- •Cutaneous melanoma located in the head/neck region
- •Evidence of satellite, in transit or local metastases / recurrences
- •Macro metastases of the SN or micro metastases of >2mm in diameter
- •Additional immune-suppressive therapy
- •Pregnant of lactating women
结局指标
主要结局
Distant metastases free survival
时间窗: 3 Years
次要结局
- Distant metastases free survival(5 Years)
研究者
研究点 (82)
Loading locations...
相似试验
招募中
不适用
Exploring an Alternative Pre-operative SLN Mapping Method Using a Magnetic Tracer and MRI for Melanoma PatientsMelanomaNCT05145829Zuyderland Medisch Centrum40
已完成
不适用
Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma PatientsMelanomaNCT05054062Zuyderland Medisch Centrum6
Unknown
不适用
Tracers for Endometrial Cancer Sentinel Node LabelingEndometrial CancerSentinel Lymph NodeNCT04665544University Medical Centre Maribor83
Unknown
不适用
Comparison Study of Different Tumor Biopsy Method for Sentinel Lymph Node Biopsy in Breast CancerBreast CancerSentinel Lymph NodeNCT04568941Shandong Cancer Hospital and Institute600
已完成
1 期
Sentinel lymph node biopsy for non-melanoma skin cancersnon melanoma skin cancersJPRN-UMIN000024452Kumamoto university100