Use of a Proliferation Saturation Index to Determine Personalized Radiotherapy Fractionation for Patients With HPV+ Oropharyngeal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Percentage of Response at Week 4 of Treatment
研究概览
简要总结
This study is to determine whether a mathematical model can be used to choose a radiation delivery method to improve the rate of a rapid response.
详细描述
Investigators hypothesize that using individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) may improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).
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
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥ 18 years
- •Pathologically (histologically or cytologically) proven diagnosis of p16+ or HPV+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx; cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, and may consist of pathology, palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
- •American Joint Committee on Cancer (AJCC) 8th edition staging T1-3 N0-1 MO
- •Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations.
- •CT or MRI performed at least 1 week apart. This can consist of diagnostic imaging and radiation therapy planning imaging.
- •No evidence of distant metastases
- •Eastern Cooperative Oncology Group Performance Status 0 to 3
排除标准
- •Age < 18
- •Positive urine pregnancy test
- •Evidence of distant metastases
- •Gross total excision of both primary and nodal disease; this includes tonsillectomy, local excision of primary site, and nodal excision that remove all clinically and radiographically evident disease
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- •Patients with a medical condition or social situation that at the discretion of the PI would preclude them from completion of the trial
研究组 & 干预措施
Radiotherapy Fractionation
Investigators will use an individual patient proliferation saturation index (PSI) to select radiotherapy fractionation (conventional fractionation or hyperfractionation) to improve the likelihood of a rapid response (defined as ≥ 32% reduction in volume at 4 weeks).
Radiotherapy fractionation: Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
干预措施: Radiotherapy fractionation (Radiation)
结局指标
主要结局
Percentage of Response at Week 4 of Treatment
时间窗: At 4 weeks of treatment
Fractionation of radiation will be individualized based on patient Proliferation Saturation Index (PSI). Objective is to increase the rate of response of ≥ 32% at 4 weeks to 63% of patients, above the expected 49%. Result is reported as percentage of participants who met the criteria for ≥ 32% reduction in tumor volume by week 4.
次要结局
- Rate of Complete Response at 2-3 Months(2-3 months post treatment)