跳至主要内容
临床试验/NCT04535895
NCT04535895撤回不适用

Simultaneous Integrated Boost (SIB) Technique in the Adjuvant Radiotherapy of Breast Cancer Patients.

Medical University of Graz2 个研究点 分布在 1 个国家开始时间: 2020年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Acute Radiation induced toxicity (grade 2 or higher)

研究概览

简要总结

Adjuvant radiotherapy after breast conserving surgery has been shown to improve both local control and overall survival. Dose escalation of the tumor bed by addition of a boost after whole breast radiotherapy reduces the risk of local recurrence in invasive breast cancer.

Simultaneous integrated boost (SIB) techniques have been shown to provide more conformal treatment plans than conventional sequential boost, in addition, SIB enables a reduction in the overall treatment time by 1 week compared to conventional boost techniques.

The proposed study is aimed at evaluating radiation-induced toxicity in patients treated with breast-conserving surgery in combination with radiotherapy using SIB technique.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Invasive breast cancer or ductal carcinoma in situ
  • Breast conserving surgery
  • Complete tumor resection
  • Treatment with adjuvant radiotherapy of the breast
  • Indication for boost Irradiation
  • Given informed consent

排除标准

  • Incomplete tumor resection
  • Mastectomy
  • Distant metastases at diagnosis
  • Unable to give informed consent

结局指标

主要结局

Acute Radiation induced toxicity (grade 2 or higher)

时间窗: Measurement 3 months after completion of radiotherapy

Toxicity score using Common Terminology for Adverse Events (CTCAE)

次要结局

未报告次要终点

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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