Patient Selection for Hypoxia Modifying Treatments Based on Functional Microregional Imaging of Tumor Vasculature, Oxygenation and Proliferation in Squamous Cell Carcinoma of the Larynx
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 5
研究概览
简要总结
The purpose of this study is to identify in a prospective manner microregional profiles of oxygenation and proliferation based on exogenous and endogenous markers that are predictive for outcome of radiotherapy in squamous cell carcinoma of the larynx and to investigate if these profiles can identify patients that are most likely to benefit from hypoxia modifying treatment strategies like ARCON (Accelerated radiotherapy combined with carbogen breathing and nicotinamide).
详细描述
Purpose
Prognostic indicators discriminate patients with good and bad prognosis. Predictive assays are tools that select patients for specific treatments or treatment modifications such that outcome will be improved relative to conventional treatment. In oncology, many prognostic indicators based on clinical or biological tumor characteristics have been described but only very few have proven to be useful as predictive assays. We have developed an imaging modality for coregistration of tumor oxygenation and proliferation at the microregional level with preservation of the tumor anatomy and the microenvironmental structure. We have strong indications that this functional imaging can be a powerful tool for identifying those patients that will profit from hypoxia modifying treatments.
Tumor oxygenation and proliferation are recognized as important determinants of the outcome of radiotherapy and possibly also of other treatment modalities in a number of tumor types and in particular in squamous cell carcinomas. Various exogenous and endogenous markers for hypoxia and proliferation are currently available which can be studied in relation to each other, the tumor architecture and the tumor microenvironment using immunohistochemistry and advanced image analysis techniques.
The purpose of this project is to identify microregional profiles of oxygenation and proliferation based on exogenous and endogenous markers that:
- Are predictive for outcome of radiotherapy in squamous cell carcinoma of the larynx.
- Can identify the patients that are most likely to benefit from hypoxia modifying treatment strategies.
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
- •Pathological confirmed squamous cell carcinoma of the larynx.
- •TNM-classification (UICC 1997, appendix I):
- •T3-4 glottic or supraglottic carcinoma
- •T2 glottic carcinoma with impaired cord mobility or subglottic extension
- •T2 supraglottic carcinoma with invasion of mucosa of base of tongue or vallecula or invasion of the medial wall of the piriform sinus.
- •any N-stage, M
- •WHO performance status 0 or
- •Age > 18 years.
- •Written informed consent.
- •Treatment in the ARCON phase III trial
排除标准
- •Prior or concurrent treatment for this tumour.
- •Severe stridor and adequate debulking of airway not possible.
- •Impaired renal function: serum creatinine above upper normal limit.
- •Use of nephrotoxic medication (including ACE-inhibitors) that cannot be discontinued for the duration of the radiation treatment.
- •Impaired hepatic function: ASAT and ALAT more than 1.5 times the upper normal limit.
- •Use of anti-convulsants that cannot be discontinued for the duration of the radiation treatment.
- •History of malignancy during the previous 5 years except basal cell carcinoma of skin, carcinoma in situ of the cervix, or superficial bladder neoplasm (pTa).