NCT04224389招募中不适用
Prospective Non-randomized Comparative Study Between IMRT and Primary Transoral Surgery in the Treatment of Squamous Cell Carcinomas of Early Local Stage of Oropharynx
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- MD Anderson Dysphagia Inventory (MDADI) global score
研究概览
简要总结
Compare patients' feelings in terms of swallowing ability assessed by the overall score of MD Anderson Dysphagia Inventory (MDADI) 2 years after starting treatment between patients who have been treated with IMRT and those who were treated by transoral surgery for a squamous cell carcinoma of the early stage oropharynx.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years old
- •ECOG performance status 0-2
- •Histologically confirmed squamous cell carcinoma
- •Primitive localization of the oropharynx on the tonsil compartment or the tongue base
- •p16 or HPV status available
- •TNM classification AJCC7th T1 or T2
- •TNM classification AJCC7th N0 or N1
- •Patient and tumor that can be treated by radiotherapy or by transoral surgery
- •Patient who has not objected to participate after being informed about the study. The patient must be able and willing to cooperate in follow-up and study visits
排除标准
- •Severe medical comorbidity or other contraindication to radiotherapy or surgery
- •Primary tumor or unresectable lymphadenopathy
- •Metastatic disease
- •History of squamous cell carcinoma of the head and neck within 5 years
- •History of radiation therapy to the head and neck
- •Inability to undergo or complete radiation therapy follow-up consultations
- •History of cancer except free of any disease for at least 5 years, with the exception of non-melanoma skin cancers
- •Inability to complete questionnaires
- •Pregnant or lactating woman
- •Patient under tutorship or curatorship, deprived of liberty or unable to do so to express consent
结局指标
主要结局
MD Anderson Dysphagia Inventory (MDADI) global score
时间窗: 2 years after inclusion
Score goes from 20 to 100. A higher score means a better ability to swallow
次要结局
未报告次要终点
研究者
研究点 (16)
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