Proton Image-guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Safety and feasibility
研究概览
简要总结
In this study the safety & feasibility of image-guided mid-treatment hyper-fractioned dose-escalation with proton therapy will be assessed for the treatment of locally advanced HPV-negative squamous cell oropharyngeal cancer
详细描述
For this study, the investigators propose a novel design to safely achieve tumor radiation dose escalation with proton therapy plus standard-of-care concomitant chemotherapy. Through mid-treatment image guidance, the tumor boost dose is determined; subsequently, only that GTV boost will receive a total dose of 80 Gy through hybrid hyperfractionation. This refers to twice-daily radiation in the last 15 fraction days. The combination of boost dose hyperfractionation and proton therapy is anticipated to prevent critical normal tissue damage within both the high- and intermediate-dose regions. This novel treatment approach aims to minimize critical toxicities while improving locoregional control for head and neck cancer patients who are at a higher risk of disease relapse.
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
盲法说明
All participants receive the experimental treatment
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Biopsy proven diagnosis of squamous cell carcinoma originating in the oropharynx.
- •Routine staging procedures, including CT of the head and neck region and chest, head and neck FDG-PET/CT and MRI (treatment planning allowed), and endoscopic evaluation when indicated.
- •Negative for p16
- •Locally advanced disease, specifically meeting all following criteria:
- •Stage III-IV
- •T-stage 2-4
- •All N-stages (N0-3)
- •Eligible for primary concurrent chemoradiation using conventionally fractionated radiotherapy 70 Gy combined with weekly cisplatin
- •Eastern Cooperative Oncology Group (ECOG) performance score ≥2
- •Age ≥18 years
- •Written informed consent
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study; patients that:
- •underwent definitive resection of their primary tumor or nodal disease, except for incisional or excisional biopsies.
- •received radiation therapy in the head and neck area in the past
- •have no detectable tumor anymore at both the primary site and lymph nodes at week 4 in treatment, because there will not be a volume to boost.
- •are unable or unwilling to give written, informed consent
- •have contra-indications for chemotherapy. This is at the discretion of the treating medical oncologist.
- •are unable to tolerate intravenous contrast for both CT and MRI, having an estimated GFR < 60 ml/min/1.73 m2 or any contraindications to gadolinium-based contrast agents.
- •have any evidence of iron overload on pre-imaging laboratory studies.
- •have other serious illnesses or medical conditions present at entry in the study, including (but not limited to): immunodeficiency virus (HIV) infection or other conditions of persistent immunodeficiency, neurologic or psychiatric disorders, active disseminated intravascular coagulation, unstable cardiac disease despite treatment or uncontrolled diabetes mellitus.
- •Women who are pregnant or breast feeding
结局指标
主要结局
Safety and feasibility
时间窗: Within 6 months after radiotherapy
The number of dose limiting toxicity (DLT) events, defined as grade ≥4 mucositis, grade ≥4 ulceration, grade ≥4 dermatitis, grade ≥4 aspiration, grade ≥4 osteonecrosis and grade ≥3 myelopathy
次要结局
- Tumor response rate(All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment)
- Completing chemotherapy regimen(End of chemotherapy)
- Completing radiotherapy regimen(End of radiotherapy)
- Disease-free, overall survival and time-weighted locoregional control(All SFP time points (baseline, weekly during RT, 6 weeks, 6, 12, 18, 24 months after treatment)
- Toxicity after chemoradiation(At 6 months after chemoradiation)