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临床试验/NCT05609058
NCT05609058招募中不适用

The Influence of Treatment Position (Prone vs. Supine) on Whole Breast Irradiation for Chinese Breast Cancer Patients :Comparative Study

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1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
300
试验地点
1
主要终点
dose distribution of GTV

研究概览

简要总结

Radiotherapy after breast conserving therapy plays an important role in early stage breast cancer patients. It not only results in a reduction in local and regional recurrence but also decrease the death rate effectively. For adjuvant radiotherapy, supine positioning is the most common approach and has multiple advantages. Due to deformability and softness of the breast, during simulation and treatment in supine position, the breast stretches over the chest wall, especially in patients with large and pendulous glands. Thus the organs at risk (OARs) received dose increased. The radiotherapeutic toxicity are unavoidable. Some present studies show that the prone positioning of patients can improve dose homogeneity and reduce the dose distribution in OARs in patients with large and pendulous glands. Chinese women have relatively small breasts, the advantages of those have not been established. Therefore, investigators compared the parameters between supine and prone positions for whole breast irradiation after conserving surgery.

详细描述

Objective To investigate the difference of target volumes and dosimetric parameters between supine and prone positions for whole breast irradiation after conserving surgery.

Methods Breast cancer patients with T1-2N0M0 stage who underwent radiation therapy after conserving surgery were enrolled. Supine and Prone scan sets were acquired during free breathing for all patients. Target volumes and organs at risk (OARs) including heart, ipsilateral lung and bilateral breast were contoured by the same radiation oncologist. The tumor bed (TB) was determined based on surgical clips. The Clinical target volume (CTV)consisted of the whole breast. The planning target volume (PTV) was CTV plus 0.5cm. The boost of PTV (PTVboost) was TB plus 0.5cm. Dosimetric parameters of target volumes and OARs were compared between supine and prone position.

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 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast cancer patients with T1-T2N0M0 stage who underwent radiation therapy after conserving surgery
  • exhibited normal arm movement aſter surgery
  • had no chronic lung diseases
  • Written informed consent forms

排除标准

  • Breast cancer patients with radical surgery
  • could not exhibit normal arm movement after surgery
  • had chronic lung diseases
  • refused informed consent forms

结局指标

主要结局

dose distribution of GTV

时间窗: 1 year

the difference of GTV (Gross tumor target) between two plans

dose distribution of CTV

时间窗: 1 year

the difference of CTV (clinical target volume) between two plans

dose distribution of ipsilateral lung

时间窗: 1 year

the difference of ipsilateral lung dose distribution between two plans

dose distribution of heart

时间窗: 1 year

the difference of heart dose distribution between two plans

dose distribution of bilateral breasts

时间窗: 1 year

the difference of bilateral breasts dose distribution between two plans

dose distribution of PTV

时间窗: 1 year

the difference of PTV (planing target volume) between two plans

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

NING_LI

professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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