CTRI/2025/09/095181尚未招募4 期
A prospective randomized study to compare Whole Brain Radiotherapy versus Stereotactic Radiosurgery or Stereotactic Radiotherapy in patients with brain metastasis from breast cancer.
Department of Radiotherapy and Clinical Oncology, PGIMER, Chandigarh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年9月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare cognitive outcome between two arms
研究概览
简要总结
Management of brain metastasis with primary from breast cancer is usually brain irradiation. In this study patients with less than 5 brain metastasis will receive radiation either by whole brain radiotherapy or by stereotactic radiotherapy techniques by randomizing patients in two arms. We aims to asses neurocognitive outcome and quality of life in both the arms.
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 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Biopsy proven case of breast cancer.
- •Those who are willing to give written informed consent.
- •1 to 5 brain lesions with maximum diameter less than 3.5cm for each lesion KPS score more than 70.
排除标准
- •Age less than 18 years KPS less than 70 Any non malignant known CNS disease that can cause neurocognitive dysfunction Number of lesion more than 5 or any lesion with size more than 3.5cm.
结局指标
主要结局
To compare cognitive outcome between two arms
时间窗: At baseline, 3 months, 6 months, 12 months after completion of treatment
次要结局
- To compare Quality of life assessment, Overall survival, Toxicity profile between two arms(At baseline, 3 months, 6 months, 12 months after completion of treatment)
研究者
Dr Shubham Jangle
Postgraduate Institute of Medical Education and Research(PGIMER),Chandigarh
研究点 (1)
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