NCT02231112Unknown2 期
Feasibility of Prone Position in Postoperative Whole Breast Radiation Therapy in Korean Breast Cancer Patient
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Irradiated cardiac dose
研究概览
简要总结
It is well known fact that postoperative whole breast radiation therapy (RT) in left breast cancer patient can cause cardiac problem according to the exposed dose. In the several studies in other countries, it was repeatedly showed that RT on prone position can reduce cardiac exposed RT dose in left breast cancer. However, the effectiveness of prone position in RT is not studied in the Korean women have relatively small breast. The investigators planned this study to evaluate the real efficacy of prone position in Korean breast cancer treated with RT.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed left breast cancer
- •20 or older age
- •less than 70 years old
- •after curative resection
- •Eastern Cooperative Oncology Group performance status 0 to 1
- •Informed consent to this study
- •Consent to contraception for 6 months after RT completion
排除标准
- •Male breast cancer
- •Combined distant metastasis
- •Status of pregnant or brest feeding
- •Previous RT history of chest or neck area
- •Indication of supraclavicular RT
- •Not indicated postoperative whole breast RT
研究组 & 干预措施
Prone position whole breast RT
Experimental
干预措施: Whole breast RT on prone position (Radiation)
结局指标
主要结局
Irradiated cardiac dose
时间窗: At simulation, expected average of 1 week
次要结局
- Irradiated lung dose(At simulation, expected average of 1 week)
- Skin change after RT(At 3 months after RT completion)
- Irradiated dose of left anterior descending artery(At simulation, expected average of 1 week)
- Irradiated dose of axillary lymphatic area(At simulation, expected average of 1 week)
- Clinical target volume (volume, homogeneity index, conformity index)(At simulation, expected average of 1 week)
- Breast shape after RT(At 6 months after RT completion)
研究者
Doo Ho Choi
Professor
Samsung Medical Center
研究点 (1)
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