Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,600
- 试验地点
- 1
- 主要终点
- Number of Participants with severe side effects
研究概览
简要总结
Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.
详细描述
Every year, new molecular agents enter the market with more and more patients receiving these treatments, especially in the metastatic setting. These molecular agents could correspond to immunotherapy and modulators of signaling pathways. More than 50% of cancer patients will receive radiation therapy during the course of their illness, including radiotherapy aimed a palliating symptoms secondary to metastatic diseases. Therefore, there will be an increasing number of patients who will be receiving radiotherapy while they are still receiving molecular agents. A better understanding of the interaction of these two treatment modalities is needed.
It is within this context that this registry was set up to gather information from physicians and patients treated with molecular agents and radiation therapy. The information being collected include diagnosis, doses received, type of targeted therapy, side effects, etc. Through this registry, we wish to determine whether there are more Grade 3 or above side effects than what is reported in the literature for these treatment modalities, when given alone or in combination. Participating patients will also describe their perceived side effects and quality of life.
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
- •Consent to be part of the AtTRIBut registry
- •Prior histological diagnosis of primary cancer.
- •If the patient has metastatic disease, there must be radiological or pathological evidence of metastasis
- •Age> 18 years
- •Receiving a molecular therapy
- •Indicated to receive radiotherapy
- •Radiation therapy can be administered using 3D conventional, IMRT or SBRT techniques.
排除标准
- •Refusal or inability to receive radiotherapy
研究组 & 干预措施
Combined modality
Patients receiving radiotherapy and a molecular agent for the treatment of cancer
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Number of Participants with severe side effects
时间窗: 1 year
CTCAE V5 Grade 3-5 toxicities
次要结局
未报告次要终点
