Artificial Intelligence for Locally Advanced Head Neck Cancer Treated With Multi-modality Adaptive RadioTherapy: Machine Learning-based Radiomic Prediction of Outcome and Toxicity (RadiomicART)
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Locoregional recurrence free survival
研究概览
简要总结
Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis. Radical RT, exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines. Despite the recent technological advancements in the field of RT, about 30-50% of patients will develop locoregional failure after primary treatment . Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life. The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic. With ART we mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment. Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as input features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization.
The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigators designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.
详细描述
Squamous cell carcinoma of the head and neck (HNSCC) is characterized by an incidence in Europe of 140.000 new cases per year, with survival rates at 5 years ranging from 25 to 65%.
Current clinical management algorithms for HNSCC patients involve the use of surgery and / or radiotherapy depending on the stage of the disease at diagnosis. Radical radiotherapy (RT), exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines.
Despite the recent technological advancements in the field of radiation therapy, about 30-50% of patients will develop locoregional failure after primary treatment of head and neck cancer. Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life of cancer patients even for long time after treatment.
The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic.
With ART the investigators mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment.
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
- •ECOG Performance status 0 to 2
- •Life expectancy > 12 months
- •Histological proven squamous cell carcinoma of the pharynx, larynx or oral cavity
- •Locally advanced stage disease classified as T3-T4 or N1-3
- •Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
- •Visible disease at the primary site on imaging performed within 4 weeks of starting treatment
- •Adequate liver function
- •Adequate renal function for infusion of iv. contrast for CT-scan and MRI-scan
- •Adequate bone marrow function
- •Written informed consent
- •No previous radiation therapy on head and neck region
排除标准
- •Inability to provide informed consent
- •Presence of distant metastases
- •Previous radiation therapy on head and neck region
- •Pregnant or breastfeeding patients
- •Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)
- •Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study
- •Allergy or contraindication to contrast agents
- •General contraindications to MRI
- •ECOG PS >=3
研究组 & 干预措施
Adaptive Radiotherapy in Head and Neck cancer patients
Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week.
At week 3 from RT start, patients will repeat contrast simulation CT with, and MRI and FDG-PET scan for treatment replanning. Patient will start with the new plan in week 4.
干预措施: Adaptive Radiotherapy (Radiation)
结局指标
主要结局
Locoregional recurrence free survival
时间窗: 1 year
Locoregional recurrence free survival in head and neck cancer patients treated with adaptive radiotherapy
次要结局
- Overall Survival(1 year)
- Progression Free Survival(1 year)
