CTRI/2025/09/094933
尚未招募
不适用
A Prospective Randomised Study To Compare The Outcome Between Conventional Radiotherapy And Hypo-Fractionated Radiotherapy Following Modified Radical Mastectomy in Female Breast Cancer Patients
Mudunuri Lakshmi Priyanka1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月30日最近更新:
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mudunuri Lakshmi Priyanka
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- a) To compare the loco regional failure between 2 arms.
概览
简要总结
The trial is for comparison of 2 regimes of Radiotherapy i.e. 50 GY in 25 fractions in one arm and 40 GY in 15 fractions in other arm ,in Post MRM Female Breast Cancer Patients to see the Locoregional failures and toxicities.Toxicities are compared using RTOG/CTCAE v5.0 criteria.
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Study participants shall be selected according to the following criteria:
- •Patients with proven Histopathological report.
- •Age between
- •70 years.
- •T1 -T2 Node positive Disease, Any T3/above, any node positive, Post Modified Radical Mastectomy. 4.Patient with adequate Lung function, Liver function, Cardiac function, and haematological parameter.
排除标准
- •Any earlier chest wall radiation
- •Any Breast Conservation Surgery
- •Very early-stage node negative Breast Disease
- •H/o Any other malignancies within first 5 years of including breast cancer
- •Any uncontrolled comorbidities and collagen vascular diseases.
- •Metastatic Disease 7.Local recurrence.
结局指标
主要结局
a) To compare the loco regional failure between 2 arms.
时间窗: 18 months
b) To compare acute toxicities as per RTOG/CTCAE v5.0 criteria between 2 arms.
时间窗: 18 months
次要结局
- To compare distant disease-free survival between 2 arms.(18 months)
研究者
Mudunuri Lakshmi Priyanka
IPGMER and SSKM HOSPITAL
研究点 (1)
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