NCT05850637已完成2 期
Phase II Study to Evaluate the Effectiveness and Toxicity of Adjuvant Ultra-hypofractionated Radiotherapy for the Treatment of Early and Locally Advanced Breast Cancer
Prevent Senior Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
Prospective phase 2 study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
详细描述
Prospective phase 2 non-randomized single-arm study to evaluate the safety and efficacy of ultra-hypofractionated adjuvant radiotherapy in 5 fractions of 5.7 Gy in patients aged over 65 years.
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
- 65 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient;
- •Pathological confirmation of invasive breast carcinoma regardless of histological subtype and hormonal profile;
- •Age greater than or equal to 65 years;
- •Breast-conserving surgery or mastectomy with or without axillary approach
- •With or without neoadjuvant or adjuvant systemic treatment
排除标准
- •Patients with previous thoracic irradiation;
- •Patients with indication for bilateral thoracic irradiation;
- •Patients with breast reconstruction with prosthesis or autologous tissue;
- •Patients with compromised surgical margins after resection;
- •pT1-pT2 pN0 patients undergoing radical mastectomy.
结局指标
主要结局
Acute toxicity
时间窗: Events of radiotherapy up to 3 months
Acute skin toxicity was evaluated the criteria followed the Standard Common Terminology Criteria for Adverse Events - CTCAE v 5.0
Late toxicity
时间窗: Events after 3 months of radiotherapy completion
Delayed skin and subcutaneous toxicities were evaluated according to the Radiation Therapy Oncology Group (RTOG) classification.
次要结局
- Overall survival(3 years)
- QOL (Quality of Life) changes(3 years)
- Locoregional free survival(3 years)
- Distant free survival(3 years)
- Cosmesis change(week 10 and week 26 after the end of the treatment)
研究者
研究点 (1)
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