NCT03418909进行中（未招募）不适用
Functional Outcome After Transoral Robotic Surgery (TORS) vs Oncological Treatment for Oropharyngeal Squamous Cell Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Altered salivatory function
研究概览
简要总结
To investigate the treatment related effects of transoral robotic surgery (TORS) or oncological treatment of oropharyngeal squamous cell carcinoma with a 1-year follow up.
详细描述
Patients are enrolled prospectively at the department of Otorhinolaryngology, Head and Neck Surgery & Audiology at Copenhagen University Hospital, Rigshospitalet.
All eligible patients with histologically verified squamous cell carcinoma of the oropharynx regardless of treatment option (as long as the intent is curative) can be included.
Outcome measures are assessed at baseline and repeated 3 and 12 months after treatment.
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
- •TORS group:
- •WHO performance status 0-2
- •Squamous cell carcinoma of the oropharynx
- •TNM: T1-2, N0-1 (without of evidence of extra capsular extent), M
- •No previous head and neck cancer
- •Absence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
- •Signed written consent.
- •Cancer eligible for surgery in the absence of significant trismus.
- •Oncological group:
- •WHO performance status 0-2
- •Squamous cell carcinoma of the oropharynx
- •Qualified for curative intended oncological treatment
- •Signed written consent
排除标准
- •TORS group:
- •Serious co-morbidity
- •Distant metastasis
- •Previous radiotherapy to the head and neck region.
- •Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
- •Oncological group:
- •Previous radiotherapy to the head and neck region.
- •Concurrent treatment eller investigations for another cancer, except carcinoma in situ.
- •Presence of factors that inhibit the patient from participate in all or parts of the study e.g. geographical, mental, cognitive or other.
- •Presence of facors that inhibit the patient from completing the treatment.
- •Previous head and neck cancer
- •Distant metastasis
结局指标
主要结局
Altered salivatory function
时间窗: 3 and 12 months follow up
Measured as change in flow rate or composition compared to baseline measurements performed prior to treatment.
次要结局
- Change to quality of life scores (EORTC QLQ-H&N35)(3 and 12 months as well as 3 years after treatment)
- Change to quality of life scores (MDADI)(3 and 12 months as well as 3 years after treatment)
- Changes in swallowing function (MBSS)(3 and 12 months as well as 3 years after treatment)
- Changes in swallowing function (FEES)(3 and 12 months as well as 3 years after treatment)
- Change to quality of life scores (EORTC QLQ-C30)(3 and 12 months as well as 3 years after treatment)
- Treatment related pain(For as long as the patient needs analgesics or up to three months)
研究者
Susanne Scott
MD, PhD student
Rigshospitalet, Denmark
研究点 (1)
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