Prediction of Outcome After Chemoradiotherapy for Head and Neck Cancer Using Functional Imaging and Tumor Biology. A Prospective, Non-commercial and Mono-centric Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- To correlate clinical, molecular and radiological predictors with outcome, as defined by locoregional control and disease free survival. In this way we will develop a prognostic/predictive model.
研究概览
简要总结
Despite uniform histopathological definition the response of locally advanced squamous cell carcinomas of the head and neck (HNSCC) to ionizing radiation differs greatly with locoregional recurrences burdening this patient population. The addition of concurrent chemotherapy and the use of altered fractionation schedules has significantly increased locoregional control and overall survival over the last decade however, this has come at the cost of increased acute and late toxicity, preventing further treatment intensification in all patients. If the investigators want to increase the therapeutic index of HNSCC, we need to be able to tailor the treatment more individually to each patient. The project aims at developing a prognostic model for head and neck cancer patients based on the combination of known clinical parameters with 1) genetic characteristics of the tumor and 2) parameters derived from diffusion weighted and dynamic contrast enhanced magnetic resonance imaging (MRI) obtained before and during treatment. The investigators plan a prospective trial where 120 patients with locally advanced head and neck cancer treated with chemoradiotherapy will be included. Prior to treatment biopsy material will be collected for genetic analysis and before and during treatment functional MRI with diffusion weighted and dynamic contrast enhanced imaging will be performed. All patients will be followed up multidisciplinary afterwards with follow-up of tumor status and toxicity.
详细描述
- BACKGROUND AND SETTING
1.1. Introduction
Concurrent (chemo-) radiotherapy (CRT) is the current standard of care for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The proximity of important functional structures with the tumour makes treatment however highly complex. While locoregional control rates have improved over the last decade, treatment related toxicity can be severe with xerostomia and dysphagia gravely complicating the patient's quality of life.
Furthermore, it becomes increasingly clear that while these tumours can be identical in location and basic histology, their response to treatment differs greatly. This implies that for a subgroup of patients, equal locoregional control rates could be achieved using a less intense and consequently less toxic treatment schedule. This in contrast to the group of patients who develop a locoregional recurrence during follow up, for whom current treatment is apparently insufficient. These patients might benefit from a more intense treatment schedule, i.e. a higher dose of radiation.
These differences in sensitivity to treatment can be explained by variations in biological, molecular and genetic factors. Clinical parameters alone are insufficient for response prediction. Identifying the different molecular and genetic factors, would help us increase the accuracy of response prediction and based on these factors tailor the treatment more individually to each patient. Therefore we want to develop a prognostic and predictive model incorporating well-defined molecular and imaging parameters which show great promise in response prediction after ionizing radiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •≥ 18 years old
- •Patients with non-metastatic locally advanced oropharyngeal cancer who will be treated with chemoradiotherapy, as decided after multidisciplinary consultation.
- •A karnofsky performance status ≥ 70%
- •Gender: Male - Female
- •Informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •Prior irradiation to the head and neck region
- •Medical contraindications for any of the planned investigations
- •Distant metastases
- •Pregnant or lactating women
- •Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study
- •Patient unlikely to comply with the protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
结局指标
主要结局
To correlate clinical, molecular and radiological predictors with outcome, as defined by locoregional control and disease free survival. In this way we will develop a prognostic/predictive model.
时间窗: 4 year time period
The predictive model will be instrumental in the individualization of treatment ensuring optimized treatment and avoiding under- and overtreatment.
次要结局
未报告次要终点
研究者
Dr. Sandra Nuyts
Full Professor, Clinical staff member
Universitaire Ziekenhuizen KU Leuven