A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery
研究概览
简要总结
This study is an observational study evaluating the clinical outcomes of mucosal sparing proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No study-specific visits or evaluations will be required. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 24 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.
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
- 是
入选标准
- •Resection of oropharyngeal tumor by transoral surgery using frozen section margin analysis resulting in a negative margin resection
- •No extensive perineural invasion after review by head and neck pathologist
- •No lymphovascular invasion after review by head and neck pathologist
- •Pathologic stage T1-2 N1-3 M0 disease
排除标准
- •T3 or T4 primary stage disease
- •Prior radiation therapy to the head and neck
结局指标
主要结局
Local Control Rate in Patients Treated with Proton Beam Therapy after Resection Using Transoral Surgery
时间窗: 24 months
Local control rate will be assessed by standard of care head and neck clinical examination during routine followup visits
次要结局
未报告次要终点
研究者
Samir Patel
Assistant Professor of Radiation Oncology
Mayo Clinic
