Weekly Single Fraction Hypofractionated Adjuvant Radiotherapy for Early Stage Breast Cancer: A Single Institution Feasibility Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Patient quality of life assessment.
研究概览
简要总结
The current study is a prospective phase II study; Eligible patients will receive hypofractionated Irradiation at a total dose of 28.5Gy in 5 once-weekly fractions of 5.7Gy in 5 weeks to the Whole Breast or chest wall with or without peripheral lymphatic irradiation.
详细描述
Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks in Kasr EL Aini Hospital.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically proven diagnosis of invasive breast adenocarcinoma.
- •Prior radical surgery (Modified Radical Mastectomy or Breast Conservative Surgery).
- •No macroscopic evidence of distant metastases at diagnosis.
排除标准
- •Prior radiation to the thoracic region.
- •Patients with synchronous or prior malignancy.
- •Positive surgical margins.
结局指标
主要结局
Patient quality of life assessment.
时间窗: six months
according to FACT-B
Patient satisfaction.
时间窗: six months
according to FACIT-TS-PS
Change in cosmetic breast appearance
时间窗: six months
according to HARVARD cosmesis scale: 1 Excellent, 2Good, 3 Fair and 4 Poor
Acute radiation toxicity assessment
时间窗: six months
according to the RTOG acute toxicity scale: 0 No visible change, 1 faint/dull erythema, 2tender/ bright +- dry desquamation, 3 patchy moist desquamation, 4 conflueunt moist desquamation, pitting edema, 0 is the best and 4 is the worse.
次要结局
未报告次要终点
研究者
Mona Salem
Assistant Lecturer of clinical oncology
Kasr El Aini Hospital