A Phase II Study of Volume and Dose De-Intensification Following Transoral Robotic Surgery (TORS) and Neck Dissection for p16+ Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 2-year locoregional control
研究概览
简要总结
This is a single-arm Phase II study of adjuvant radiation for locally advanced p16+ oropharyngeal squamous cell carcinoma. The main purpose of this research is to determine the likelihood of cancer growing back in the throat or in the neck two years after completion of radiation if lower doses of radiation are used to a smaller area of the head and neck region than is currently used in standard of care.
详细描述
This is a single arm Phase II study of adjuvant radiation for locally-advanced p16+ oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N2b, M0 disease (per AJCC 7th ed) with <5 positive lymph nodes, will be eligible. Patients will have undergone TORS primary site resection and ipsilateral neck dissection. Patients will undergo radiation dose reduction and target volume reduction.
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
- •Patients >= 18 years old
- •Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry
- •Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 7th Ed)
- •Pathologic N0, N1, N2a, or N2b disease (per AJCC 7th Ed), with < 5 positive lymph nodes
- •ECOG Performance Status 0-1
排除标准
- •Prior radiation therapy to the head and neck
- •Presence of T4 disease
- •Presence of N2c or N3 neck disease (per AJCC 7th Ed)
- •>= 5 lymph nodes
- •Presence of distant metastatic disease
研究组 & 干预措施
Arm 1
All patients will have the volume treated and radiation dose delivered to the regional lymphatics decreased according to the characteristics of the primary site and involved lymph nodes. The high risk neck will receive 50 Gy instead of 60 Gy, and the treated volume of the contralateral low risk neck will be reduced and receive only 45 Gy.
干预措施: Radiation Therapy (IMRT or IMPT) (Radiation)
结局指标
主要结局
2-year locoregional control
时间窗: 2 years
Number of patients with 2-year locoregional control, defined as control at the primary site and in the neck, in patients undergoing de-intensified radiation to the primary site and regional lymphatics after Transoral Robotic Surgery (TORS) and neck dissection for p16+ oropharyngeal squamous cell carcinoma (OPSCC)
次要结局
- Number of participants with change in circulating human papillomavirus(HPV) DNA over the course of treatment(2 years)
- Metastasis-free survival(3 years)
- Patient reported quality of life outcomes(2.5 years)
- Overall survival(5 years)
- Treatment-related toxicity(2 years)
- Differences in toxicity between Intensity-modulated radiation therapy (IMRT) and Intensity Modulated Proton Therapy (IMPT)(1 year)
- 2-year progression-free survival(3 years)