A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Locoregional control
研究概览
简要总结
This is a single-arm, phase II study to establish the safety of reducing radiation dose in selected HPV-Associated OPSCC patients receiving adjuvant radiation after TORS and neck dissection. This protocol also allows for sparing of the primary resection bed, in appropriate patients, as previously published by our group and found to be safe and effective.
详细描述
This is a single-arm Phase II non-inferiority study of adjuvant radiation for locally-advanced HPV-Associated oropharyngeal squamous cell carcinoma. Patients with pT0-T3, N0-N1, M0 disease (per AJCC 8th Edition), detectable pre-operative and undetectable postoperative ctHPVDNA will be eligible. Patients will have undergone TORS primary site resection and neck dissection. Patients will undergo adjuvant RT +/- guideline-indicated chemotherapy. The neck and the primary site will be considered separately.
The primary objective of the study will be to determine the 2-year locoregional control (LRC) rate. Secondary objectives include measures of toxicity (as measured by CTCAE, version 5.0), patient-reported QOL (as measured by the MDASI and MDADI questionnaire), progression-free survival, metastasis-free survival, and overall survival. Differences between patients treated with IMRT and proton therapy in terms of toxicity and QOL will serve as another secondary objective.
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 or HPV-positive by In-Situ Hybridization
- •Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed)
- •Pathologic N0-N1 disease (per AJCC 8th Ed)
- •Preoperative plasma ctHPVDNA of ≥ 50 copies/mL
- •Undetectable postoperative plasma ctHPVDNA
- •ECOG Performance Status 0-1
排除标准
- •Prior external beam radiation therapy to the head and neck
- •Presence of T4 disease
- •≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition)
- •Presence of distant metastatic disease
- •Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Shortened Course Adjuvant Radiotherapy
The volume treated to the regional lymphatics will be according to the characteristics of the primary site and involved lymph nodes. The dose of radiotherapy delivered will be 30 Gy, over the course of 10 treatments (5 daily treatments/week).
Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In patients requiring treatment of the primary site, reduced dose (30 Gy) will be delivered.
干预措施: Shortened Course Adjuvant Radiotherapy Following TORS (Radiation)
结局指标
主要结局
Locoregional control
时间窗: 2 years
To determine whether disease recurs locally (at primary site) or in regionally in the nodes of the neck
次要结局
- Metastasis-free survival(2 years)
- Overall survival(2 years)
- Progression-free survival(2 Years)
- Differences in toxicity between patients receiving IMRT and patients receiving PBT(2 years)
- Patient-Reported Quality of Life using MDASI-HN(2 years)
- Patient-Reported Quality of Life using MDADI(2 years)