NCT00887523已完成不适用
Randomized Controlled Trial Comparing Prone and Supine Intensity-modulated Radiotherapy (IMRT) After Breast-conserving Surgery in Patients With Large Breast Volume at High Risk for Skin Toxicity and Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- acute moist desquamation
研究概览
简要总结
84 patients with a cup size C or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.
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
- 否
入选标准
- •female patients
- •multidisciplinary decision of adjuvant whole-breast irradiation (WBI) after lumpectomy for breast cancer
- •minimum 18 years
- •informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •mastectomy
- •need for axillary irradiation
- •bilateral breast irradiation
- •previous irradiation at the same time
- •mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
结局指标
主要结局
acute moist desquamation
时间窗: weekly during radiotherapy and 1 month after radiotherapy
次要结局
- time of treatment delivery(daily during radiotherapy)
- Acute skin toxicity other than moist desquamation(weekly during radiotherapy and 1 month after radiotherapy)
- Quality of life(at 1 year and 2 years after radiotherpay)
- Late skin toxicity(at 6, 12, 18 and 24 months after radiotherapy)
- skin and lung fibrosis assessed with computed tomography(before radiotherapy and 1 month and 1 year after radiotherapy)
- dose-volume parameters(of planning)
- single nucleotide polymorphisms associated with skin toxicity and breast fibrosis(1 blood sample before radiotherapy)
研究者
研究点 (2)
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