跳至主要内容
临床试验/NCT05589701
NCT05589701招募中不适用

Prospective Registry Trail COMparing Stereotactic Body Radiotherpy (SBRT) to Conventional PAlliative RadioTherapy (CRT) in Patients With Spinal Metastases

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年12月12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
入组人数
100
试验地点
1
主要终点
Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.

研究概览

简要总结

This is a single institutional registry-based, prospective, observational study to describe radiation oncologists' decision making during evaluation of patients and to compare real-world outcomes of SBRT vs CRT.

A registry-based trial involves observing the effect of something without manipulating it.

详细描述

The purpose of this study is to study the differences between CRT and SBRT. The investigator's are assessing radiation oncologists' decision-making during the evaluation of patients with spinal metastases by requesting radiation oncologists complete a questionnaire. Additionally, the investigator's will compare outcomes, including local progression, pain response and overall survival between SBRT and CRT. By collecting this information, the investigator's will develop an evidence-based algorithm that may be used to support medical decision-making for others with spinal metastases in the future.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults 18 years of age or older.
  • •Patients seen at the Princess Margaret Cancer Centre with painful spinal metastases amenable to radiation treatment.
  • •Confirmation of diagnosis: a) Known/documented prior histological cancer diagnosis
  • •Able to provide written consent
  • •ECOG performance status 0-3

排除标准

  • •Prior radiotherapy, with fields overlapping, resulting in excessive doses to organs at risk
  • •Lymphoma, myeloma or germ cell malignancies

研究组 & 干预措施

Stereotactic Radiotherapy (SBRT)

Standard of care stereotactic radiotherapy.

干预措施: Radiotherapy (Radiation)

Conventional Radiotherapy (CRT)

Standard of care conventional radiotherapy.

干预措施: Radiotherapy (Radiation)

结局指标

主要结局

Describe physician decision-making when making a recommendation for SBRT vs CRT in spine metastasis patients requiring radiation.

时间窗: 2 years

Physician's decision making will be assessed by a questionnaire containing 6 questions, including questions on variations of practice and the role of a number of factors that may influence a physician's recommendation for spine metastasis patients requiring radiation (SBRT vs CRT).

次要结局

  • Assess local progression free survival.(2 years)
  • Measure pain response(2 years)
  • Assess adverse events(2 years)
  • Measure overall survival(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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