Comparative evaluation of three-weeks versus one week-adjuvant postoperative radiotherapy regimens in breast cancer patients using intensity modulated radiotherapy technique : A randomized controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary end point is ipsilateral breast tumour relapse
研究概览
简要总结
All biopsy proven postoperative early and locally advanced invasive breast carcinoma patients presenting at the outpatient department of Radiation Oncology will be enrolled in the study as per the inclusion criteria .
A detailed history and clinical examination will be done along with baseline routine blood investigations and imaging.
Patients will be explained about the need for post-operative radiotherapy and study details will be explained in detail and written informed consent will be taken.
Patients will be allocated into two arms based on computer generated random tables.
Patients in arm A will receive RT dose of 40Gy in 15 fractions in 3 weeks.
Patients in arm B will receive RT dose of 26Gy in 5 fractions in 1 week.
Patients will be assessed for acute and late toxicities weekly during treatment , 2 weeks and 4 weeks after treatment.
Patients will be called for follow up after 1 month ,3 months and 6 months after completion of treatment and will be monitored for loco-regional control rate and documented .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All biopsy proven post-operative early and locally advanced invasive carcinoma breast patients.
排除标准
- •Stage 4 disease Metastatic carcinoma breast Pregnancy and lactation Bilateral breast tumours Contraindication to radiotherapy eg: collagen vascular disorders History of prior radiation therapy to chest wall.
结局指标
主要结局
Primary end point is ipsilateral breast tumour relapse
时间窗: Patients will be assessed clinically for loco-regional control rate at the end of treatment , 3 months and 6 months after completion of treatment.
次要结局
- Acute and Sub-acute toxicities and loss of patient compliance .(Toxicity assesment will be done weekly during treatment and at 2 weeks and 4 weeks after treatment.)
研究者
Dr Sivaranjani P
All India Institute Of Medical sciences