Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive HPV in situ hybridization (ISH) and/or positive HPV PCR
- •Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment
- •Zubrod/ECOG score of 0-1
- •Weight loss <10% in the 3 months prior to diagnosis
- •≥ 18 years of age
- •No prior chemotherapy for their current cancer diagnosis
排除标准
- •Prior radiotherapy to the head and neck
- •Medical contraindications to radiation therapy
- •Absence of gross disease on imaging prior to beginning radiation therapy
- •Distant metastatic disease
- •Medical contraindication to PET/CT
- •History of active cancer other than non-melanoma skin cancer within the last 5 years
研究组 & 干预措施
Interim PET-CT with dose de-escalation
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
干预措施: De-escalated radiation dose (Radiation)
Interim PET-CT with dose de-escalation
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
干预措施: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) (Other)
Interim PET-CT with standard radiation
干预措施: Standard radiation dose (Radiation)
Interim PET-CT with standard radiation
干预措施: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) (Other)
结局指标
主要结局
Progression-free survival
时间窗: from initiation of radiation therapy through study completion, an average of 2 years
defined as the time between initiation of radiation treatment and the first documented recurrence of disease or death due to any cause as measured by medical record abstraction
次要结局
- locoregional progression-free survival(from initiation of radiation therapy through study completion, an average of 2 years)
- overall survival(from initiation of radiation therapy through study completion, an average of 2 years)
- Long term adverse events(2 years)
- progression free survival correlation in PET/CT responders versus PET/CT non-responders(2 years)
- distant disease-free survival(from initiation of radiation therapy through study completion, an average of 2 years)
- Acute adverse events(7 weeks)