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临床试验/NCT01973634
NCT01973634已完成2 期

Comparison of Acute Toxicity and Cost Between Whole Breast Irradiation With Sequential Boost and Simultaneous Integrated Boost After Breast Conserving Surgery

University Hospital, Ghent2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
170
试验地点
2
主要终点
Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.

研究概览

简要总结

Whole breast irradiation (WBI) after breast conserving surgery for early-stage breast cancer halves the recurrence risk and reduces the breast cancer death by about one sixth. A sequential boost (SeqB) dose to the tumour bed further improves local control, but also increases the risk of late skin toxicity and cosmetic changes. At Ghent University Hospital WBI is prescribed in 15 fractions of 2.67 Gy according to the START-B hypofractionation scheme. A sequential boost is typically given in 4 to 8 extra fractions which prolongs the overall treatment time. The boost dose can also be delivered within the 15 fractions of WBI, the so-called simultaneous integrated boost (SIB). SIB shortens the overall treatment time which is convenient for the patient and the radiotherapy department. In this study we wish to test the hypothesis of acceptable skin toxicity and reduced cost with SIB using hypofractionated prone intensity modulation radiotherapy IMRT with topographical dose painting, a technique recently developed in our group. Patients are randomized between SeqB and SIB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Degree of acute moist desquamation during or in the first 2 weeks after radiotherapy.

时间窗: weekly during radiotherapy, 2 weeks after the end of radiotherapy.

Clinical inspection of the treated breast.

次要结局

  • Degree of acute skin toxicity.(Weekly during radiotherapy and 2 weeks after the end of radiotherapy.)
  • Measurement of costs for the patient for the full treatment.(Over the period of radiotherapy treatment, with a maximum of 5 weeks.)
  • Degree of chronic skin toxicity and cosmesis after radiotherapy.(2 weeks, 1 year, 2 years and 5 years after radiotherapy.)
  • Quality of life after radiotherapy.(2 weeks, 1 year, 2 years and 5 years after radiotherapy.)
  • Biomarker analysis.(Blood sample within 1 week before the start of radiotherapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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