ACTRN12611000713998尚未招募未知
A phase III Multicenter Randomised Trial in High Risk Non Melanoma Skin Cancer of Sentinel Lymph Node Biopsy and Lymphadenectomy versus Nodal Observation on Disease Free and Overall Survival.
Sydney Head and Neck Cancer Institute0 个研究点目标入组 300 人开始时间: 2011年7月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants must be able to give fully informed consent and have non melanoma skin cancer with any of the following clinicopathologic risk factors:
- •-size > 2cm
- •-invasion into subcutaneous fat or tumour thickness > 5mm
- •-poorly differentiated phenotype
- •-perineural invasion
- •-lymphovascular invasion
- •-local recurrence
- •-location of lesion on lip or ear
- •-immunocomprimised host (post organ transplant, chemotherapy)
- •-carcinoma developing in pre-existing scar
排除标准
- •Subjects meeting any of the following criteria will be excluded from participation:
- •-Clinical evidence of distant metastases
- •-previous surgery that is believed to have altered the local lymphatic drainage since emergence of lesion
- •-allergy to patent blue dye or radiocolloid
- •-significant cognitive or psychiatric disorder (inability to understand informed consent)
- •-pregnancy/lactation
- •-inability to complete 5 years of follow up
- •-Participation in concurrent experimental protocols or alternative therapies that might confound the analysis of this trial. Adjuvant therapy protocols after recurrence are acceptable.
研究者
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