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临床试验/NCT06528912
NCT06528912招募中不适用

Standard Follow-up Program (SFP) for Neuro-oncology Cancer Patients Treated With Radiotherapy

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Radionecrosis

研究概览

简要总结

Standardised evaluation of baseline data regarding tumor-, patient- and treatment-characteristics as well as follow-up data regarding tumor- and clinical-outcome of neuro-oncology patients treated with radical/curative radiotherapy.

Motive:

Currently there is limited data on dose-effect relationships of tissues and structures in and around the brain. This lack of knowledge hampers patient selection for proton therapy, technique innovations, and accurate prediction of treatment outcome.

Goal:

To evaluate the selection for radiation treatment, obtain more knowledge on dose-effect relationships and enable insight in necessary treatment technique innovations that would improve treatment outcome.

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

入选标准

  • Patient with neuro-oncological cancer
  • Patient receiving a radiotherapy dose XXX Gy

排除标准

  • Failure to comply with any of the inclusion criteria

结局指标

主要结局

Radionecrosis

时间窗: Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.

Treatment associated radionecrosos measured with CTCAE

Treatment associated CNS toxicity

时间窗: Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.

Treatment associated CNS Toxicity

次要结局

  • Progression free survival(Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy)
  • Treatment associated non-CNS toxicity(Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy)
  • Overall survival(Before start of radiation therapy, at 2,5 years; 5 years 7,5 years, 10 years and 12,5 years after completion of radiation therapy.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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