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临床试验/NCT04115267
NCT04115267招募中不适用

Attribution of Toxicities Due to Radiotherapy and Immuno-Biological Therapies - Registry

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 3,600 人开始时间: 2019年9月13日最近更新:
适应症
干预措施

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

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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