A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- N0 Nodal Control Rate
研究概览
简要总结
The dose of radiation most commonly used to treat oropharyngeal cancer results in side effects including sores in the mouth and throat, dry mouth and thick saliva, loss or altered taste, swallowing problems including pain or inability to swallow requiring feeding tubes to be placed in the stomach, hoarseness or breathing problems from swelling requiring tracheostomy or a hole surgically placed in the windpipe to allow the patient to breathe, nausea and vomiting, fatigue and loss of energy, decreased hearing from fluid behind the ear drums in the middle ear, skin redness tenderness and blistering.
The purpose of this study is to determine if the investigators can reduce the dose of radiation to the lymph nodes in the neck that may contain cancer cells that are not detected by physical examinations or radiologic studies (CT scans, PET CT scans, or MRI scans) in order to reduce the side effects from treatment and still adequately kill any cancer cells that may be contained in those lymph nodes.
详细描述
A Pilot Single Arm Study of Intensity Modulated Radiation Therapy Elective Nodal Dose De-Escalation for HPV-Associated Squamous Cell Carcinoma of the Oropharynx.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 must be clinically referred for radiation for stage I-IVb OPSCCA
- •tumor must be HPV-associated p16+
- •patient must be able to lie flat and tolerate immobilization systems
排除标准
- •patients may not be receiving any investigational agents
- •prior radiation to head and neck
- •any other malignancy except non-melanomatous skin cancer or a carcinoma not of head and neck origin with patient being disease free for at least 5 years
- •any major medical, psychiatric, or neurologic illness
- •pregnant or breastfeeding women
结局指标
主要结局
N0 Nodal Control Rate
时间窗: Up to 3 years post treatment
Effectiveness of 39.6 Gy (Gray) radiation on tumor control in the clinically uninvolved (N0) cervical lymphatics of patients with p16+ oropharyngeal squamous cell carcinoma (OPSCCA)
次要结局
- Dose Volume Histograms (DVH)(Up to 3 years post treatment)
- Adverse Events of Participants Treated With 39.6 Gy Radiation to the Clinically Uninvolved Neck(Up to 3 years post treatment)
- Progression Free Survival Following 39.6 Gy Radiation to the Clinically Uninvolved Neck(Up to 3 years post treatment)
研究者
Paul W. Read, MD
Professor
University of Virginia
