NCT05600842招募中不适用
De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- 2-Year Progression-Free Survival
研究概览
简要总结
This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.
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
- •Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.
- •Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;
- •History/physical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;
- •Age ≥ 18;
- •PET/CT within 6 weeks prior to registration;
- •Patients must sign a study-specific informed consent form prior to study entry.
- •Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
排除标准
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
- •Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;
- •Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;
- •Receipt of prior radiotherapy that would result in overlap with proposed field.
结局指标
主要结局
2-Year Progression-Free Survival
时间窗: Given the natural history of this disease, PFS will be monitored up to 2 years from registration
Progression-free survival (PFS) is defined as the time from registration to disease progression or death from any cause.
次要结局
- Overall survival(Given the natural history of this disease, overall survival will be monitored for up to 2 years from registration)
- Local-regional control(Given the natural history of this disease, local-regional control will be monitored up to 2 years from registration)
研究者
Eric Chen
Assistant Professor
University of California, Irvine
研究点 (2)
Loading locations...
相似试验
招募中
不适用
De-escalation of Radiation Dose in HPV-associated OPC Utilising FMISO PET (DE-RADIATE)HPV Positive Oropharyngeal Squamous Cell CarcinomaNCT06307015Royal North Shore Hospital25
招募中
2 期
PD-1 Inhibitor Based Induction Chemotherapy Followed by De-escalation Protocols in OPSCCOropharyngeal CancerNCT06156891Fudan University60
招募中
2 期
HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell CarcinomaSquamous Cell Carcinoma of the OropharynxNCT05962242University of Virginia90
撤回
不适用
Radiation Exposure Reduction Protocol for Minimally Invasive Lumbar Decompression (mild) TechniquesRadiation ExposureLumbar Spinal StenosisNCT06651138University of Kansas Medical Center
进行中（未招募）
2 期
Shortened Course Adjuvant Radiotherapy Following TORSHPV-Associated Oropharyngeal Squamous Cell CarcinomaNCT05714657Abramson Cancer Center at Penn Medicine104