Prospective Multicenter Cohort Study for the Analysis of Correlation Between Dosimetric Parameters and RANV (Radiation Associated Nausea and Vomiting) in Patients With Head and Neck Cancer Undergoing Exclusive Radiotherapy (RT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 14
- 主要终点
- Evaluation of nausea (acute toxicity) using CTCAE V5.0
研究概览
简要总结
This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).
The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer.
详细描述
The use of Intensity Modulated Radiation Therapy (IMRT) has become increasingly common in clinical practice for the treatment of head and neck tumors. Despite the well-documented dosimetric advantages of IMRT, there has been a gradual recognition of toxicity profiles that are characteristic and distinct from those known in the era of 2D and 3D techniques, associated with the so-called "dose bath" typical of all intensity-modulated treatments. Among these, one of the main concerns is Radiation-Associated Nausea and Vomiting (RANV), the persistence and severity of which can significantly compromise the quality of life for patients.
Consequently, there has been a growing need to more thoroughly assess the clinical and dosimetric risk factors associated with the onset of RANV in this population. Although several authors have already investigated this aspect, most studies available to date consider cases where concurrent chemotherapy administration may affect the assessment of the outcomes of interest. Even when exclusively focusing on studies centered on IMRT (without concurrent chemotherapy), the generalization of results is at least partially affected by the fact that these are retrospective series with a relatively small population (23-130 patients).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 aged ≥ 18 years
- •Diagnosis of primary head and neck neoplasm in the following subsites: oropharynx, nasopharynx, oral cavity, paranasal sinuses, salivary glands, and neoplasms with an unknown primary focus.
- •Curative radiotherapeutic treatment with photons or protons using 3D conformal or Intensity Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT), Tomotherapy; both photon and proton treatments are allowed.
- •Ability to prospectively collect and anonymously submit clinical data related to the patient, pathology, and treatment characteristics (including the radiotherapy treatment plan in RT.dose format) to a single referring center.
- •Ability to prospectively collect and anonymously submit DICOM (Digital Imaging and COmmunication in Medicine) files related to pre-RT magnetic resonance imaging (MRI) to a single referring center.
- •Ability to collect acute toxicity data (mucositis, xerostomia, nausea, vomiting, weight loss) during radiotherapy and at three months post-treatment.
- •Ability to undergo a clinical follow-up examination three months after the completion of radiotherapy.
- •Willingness to provide written informed consent for the anonymous use of data for research purposes.
排除标准
- •Patients undergoing chemotherapy treatment (neoadjuvant or concurrent with radiotherapy).
- •Patients with local and/or locoregional recurrence of head and neck disease.
- •Patients previously treated with oncologic interventions in the head and neck region.
- •Patients with synchronous distant metastases at the time of diagnosis.
- •Inability to comprehensively collect baseline data related to the patient, pathology, and treatment characteristics (including the treatment plan) and follow-up data.
- •Inability to obtain written informed consent for the anonymous use of data for research purposes.
结局指标
主要结局
Evaluation of nausea (acute toxicity) using CTCAE V5.0
时间窗: 3 months
Dose-response correlation between central nervous system (CNS) structures and substructures and nausea (Nausea will be scored using Common Terminology Criteria for Adverse Events- CTCAE- v 5.0
次要结局
- Development of machine-learning predictive models for the onset of nausea(1 year)
- Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire(3 months)
- Identification of the organs at risk most strongly correlated with the onset of nausea(3 months)
- Identification of dosimetric cutoffs for the onset of nausea(3 months)
- Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques(3 months)