A Prospective Study of One Week Accelerated Hypo-fractionation Adjuvant Radiotherapy in High-risk Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Acute toxicity
研究概览
简要总结
- Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth.
- Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer.
- More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin.
- •Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology.
- •All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy
排除标准
- •Metastatic breast cancer at the time of diagnosis proved clinically or radiologically.
- •Postoperative positive margin.
- •Carcinomas in situ.
- •Mesenchymal breast lesions.
- •Locoregional recurrent breast cancer.
- •Synchronous bilateral breast cancer.
- •very early breast cancer (T1-2N0M0,T1N1M0).
结局指标
主要结局
Acute toxicity
时间窗: 3 months
Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy.
Chronic toxicity
时间窗: 6 months post treatment up to 2 years
Rate of chronic toxicity grade 2 or higher ( NCI_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment.
Local recurrence
时间窗: Up to 2 years
Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.
Patient compliance
时间窗: From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm
Compliance to treatment (number of interrupted days of radiotherapy.
次要结局
- Overall survival(From time of diagnosis up to 2 years post radiotherapy)
研究者
Nahla Mohamed Elmahdy
Assistant lecturer of clinical oncology sohag university hospitals
Sohag University