NCT04767048招募中2 期
Interest of Bilateral Basic Tongue Mucosectomy Assisted by Robot or Laser in Combination with Tonsillectomy in the Assessment of Prevalent Cervical Lymphadenopathy: a Randomized Phase II Study
Centre Francois Baclesse5 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2021年6月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 5
- 主要终点
- Detection of primary cancer
研究概览
简要总结
We are proposing a randomized phase II study to assess the benefit of bilateral robot-assisted or laser basal tongue mucosectomy in combination with tonsillectomy in the assessment of prevalent cervical lymphadenopathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
tonsillectomy +/- bilateral mucosectomy
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a prevalent head and neck lymphadenopathy with positive or non-contributory fine needle aspiration, or having had an adenectomy revealing a metastasis of squamous cell carcinoma, a PET examination, an injected cervico-thoracic CT and an ENT work-up (nasofibroscopy) not finding a primary tumor
- •Performance Status < 2
- •Patient aged 18 or over
- •Patient affiliated with social security system
- •Informed consent signed
排除标准
- •History of squamous cell carcinoma of the VADS or skin of the face.
- •History of cervico-facial radiotherapy
- •Primary tumor discovering during pan-endoscopy
- •Inexposable patient lead not to possible mucosectomy
- •Uncontrollable hemostasis disorders (contraindication to tonsillectomy and basic bilateral mucosectomy of language)
- •Distant metastases
- •Lymphadenopathy inoperable
- •Patient with a contraindication to radiotherapy
- •Pregnant or breastfeeding woman
- •Women of childbearing potential without effective contraception
- •Patient under guardianship or unable to give informed consent
- •Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons
结局指标
主要结局
Detection of primary cancer
时间窗: At surgery
Proportion of patients with primary cancer detected with surgery
次要结局
未报告次要终点
研究者
研究点 (5)
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