Prospective Randomised Study Comparing Accelerated Partial Breast Irradiation with Whole Breast Irradiation By 3 Dimensional Conformal Radiotherapy In Patients With Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acute radiation toxicity after radiotherapy treatment
研究概览
简要总结
Radiotherapy is an essential treatment modality for breast cancer in women. In this study, patients with early stage breast cancer post breast conserving surgery will receive radiotherapy by either accelerated partial breast irradiation with a dose of 22.5Gy in 3 fractions or whole breast irradiation with a dose of 26Gy in 5 fractions by using 3 dimensional conformal radiotherapy technique by randomizing patients in 2 arms. We aim to assess and compare acute toxicity, cosmesis and late toxicity in both arms. Also, we will assess quality of life in the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Tumor size T1-T2
- •Nodes negative
- •Non metastatic
- •Negative surgical margin
- •Unicenteric
- •Lymphovascular invasion absent
- •No neoadjuvant chemotherapy given.
排除标准
- •Tumor size (T3,T4)
- •Positive nodes
- •Metastatic
- •Positive surgical margin
- •Multicentric
- •Multifocal
- •Lobular carcinoma in situ.
结局指标
主要结局
Acute radiation toxicity after radiotherapy treatment
时间窗: At 1 month, 2 months and 3 months after radiotherapy treatment
次要结局
- Cosmesis(At 3 months, 6 months and 9 months after radiotherapy treatment)
- Late toxicity(At 6 months and 9 months after radiotherapy treatment)
- Quality of life(At 3 months and 6 months after radiotherapy treatment)
研究者
Dr Monsu Rathod
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh