Surveillance of the Cohort of Patients Overexposed in a Course of Conformational Radiotherapy for a Prostate Adenocarcinoma in Jean MONNET Hospital, Epinal, France. Epinal: Patients Overexposed for a Prostate Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 1
- 主要终点
- To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
研究概览
简要总结
Background:
Between 2000 and 2006, 433 patients were overexposed (8% to 10%) during a course of conformal radiotherapy for a prostate adenocarcinoma in Jean MONNET hospital, Epinal, France. Among them, twenty four patients received an additional mean dose about 20%, due to an inappropriate use of the treatment planning system. Severe adverse events (proctitis, cystitis, and tissue necrosis) have occurred among most of these overexposed patients. We propose to develop several research programs in order to increase the scientific knowledge on iatrogenic effects related to overexposure of ionizing radiation, by studying their relationship with dosimetric, clinical, biologic and genetic characteristics.
Aim of the study:
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
Primary study endpoint:
Incidence and severity of adverse events related to radiotherapy (according to SOMA - LENT and CTCAE scales).
详细描述
Secondary study endpoint:
- Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.
- Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity
- Gene associations with risks for adverse events related to radiotherapy
- Levels of circulating microparticles and bystander effect after irradiation
Inclusion criteria:
Consecutive patients treated for a prostate adenocarcinoma in the radiation department of the Jean MONNET Hospital between 2000 and 2006.
Potential. Better identification of patients at high risk of adverse events related to radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •provision of informed consent
- •patient treated for prostate adenocarcinoma and overexposed during radiotherapy in a prostate adenocarcinoma in the radiation department of the a prostate adenocarcinoma in the radiation department of the Jean MONNET hospital/ service de radiotherapies between 2000 and 2006
排除标准
- •No provision of informed consent
- •Patient with disease worsening and in incapacity to move about to CHJM
结局指标
主要结局
To correlate the received doses, the volume of irradiated normal tissues, the events, with biologic, phenotypic and genetic data.
时间窗: At the inclusion visit
次要结局
- Evaluation of T-lymphocyte apoptosis to predict radiation-induced late toxicity(At the inclusion visit)
- Correlation between adverse events and radiation doses with biologic, phenotypic and genetic data.(At the inclusion visit)
- Gene associations with risks for adverse events related to radiotherapy(At the inclusion visit)
- Levels of circulating microparticles and bystander effect after irradiation(At the inclusion visit)