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临床试验/NCT02736786
NCT02736786已完成不适用

A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年3月最近更新:
适应症

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

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

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samir Patel

Assistant Professor of Radiation Oncology

Mayo Clinic

研究点 (1)

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