跳至主要内容
临床试验/NCT02704312
NCT02704312终止不适用

A Feasibility Study of Patient Comfort and Dosimetry Evaluation in Prone Breast Radiotherapy.

University Hospital Center of Martinique1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2015年11月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
11
试验地点
1
主要终点
Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk

研究概览

简要总结

Compare dosimeters in both positions (prone and decubitus) for each patient

详细描述

Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •Patients with primary breast cancer and in whom conservative post- surgery radiation therapy for breast cancer is prescribed.
  • •Patients aged over 18 years
  • •Patients with indication for conservative surgery.
  • •Resection should be in healthy margin.
  • •Women of childbearing potential must satisfy a negative pregnancy test at the screening visit and use effective contraception as determined by the physician of the patient throughout the study.

排除标准

  • •Minor Patient
  • •Patients whose tumor resection is incomplete
  • •Patients with an indication of mastectomy
  • •Patients with a history of radiation therapy of the chest
  • •Pregnant women, lactating, or of childbearing age without effective contraception.
  • •Patients who had more than 4 scanners in one year. ( Scanner cervical , thoracic, or abdominal
  • •Patients with an incompatible condition with monitoring protocol (psychiatric disorder, uncontrolled disease).
  • •Patient unable to respond to a questionnaire

研究组 & 干预措施

Radiotherapy techniques

Experimental

Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk. The technique used is that of which the dose on the organs at risk is as low as possible, and whose dose to the target volume is the closest possible to the prescribed dose (100% of the prescribed dose)

干预措施: Radiotherapy by Prone and decubitus (Radiation)

结局指标

主要结局

Quantitative Physics: dosimetric comparison of doses in target volumes and organs at risk

时间窗: From baseline to 5 weeks

次要结局

  • Quality of Life Questionnaire(Baseline and Follow up month 3, 12, 24 and 36)

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (1)

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