Stereotactic Radiosurgery vs Whole Brain Radiotherapy in Breast Cancer With Brain Oligometastasis- A Randomised Controlled Phase 3 Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Overall survival
研究概览
简要总结
This trial aims to assess the impact of SRS on overall survival, PFS, radiation toxicity and quality of life as compared to WBRT in oligometastatic brain disease in breast cancer patients. Total 98 patients with breast cancer with brain oligo-metastases will be included. The WBRT dosage schedule will be 30 Gy in 10 fractions over 2 weeks. For tumors with 2cm, SRS dose of 22 to 25 Gy will be delivered and tumor larger than 2 cm will be treated with doses of 18 to 20 Gy.
详细描述
AIMS AND OBJECTIVES To assess the impact of SRS on overall survival, brain tumour recurrence and radiation toxicity with oligometastatic brain metastasis as compared to patients who receive WBRT.
Primary End Point: Overall Survival (OS) Secondary End Points: Progression Free Survival (PFS) Toxic Effects of Radiation Quality of Life DETAILED RESEARCH METHODOLOGY Study Setting: Department of Radiotherapy and Oncology, Post Graduate Institute of Medical Education and Research, Chandigarh Study Design: Prospective hospital based study
Inclusion criteria:
- Age >=18 years
- Willing to provide informed consent
- Histologically confirmed malignancy with metastatic disease detected on imaging.
- ECOG performance status 0-1
- 1 to 5 brain metastases, each with a maximum diameter of no more than 3.5 cm on contrast enhanced magnetic resonance imaging(MRI) scans.
Exclusion criteria
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18 years
- •Willing to provide informed consent
- •Histologically confirmed malignancy with metastatic disease detected on imaging.
- •ECOG performance status 0-1
- •1 to 3 brain metastases, each with a maximum diameter of no more than 3 cm on contrast enhanced magnetic resonance imaging(MRI) scans
排除标准
- •Serious medical comorbidities
- •ECOG >= 2
- •Prior Brain Radiotherapy
- •>3 brain metastasis
- •Maximum diameter >4cm on MRI
结局指标
主要结局
Overall survival
时间窗: 1 year
From date of randomization till death due to breast cancer
次要结局
- Progression Free Survival (PFS)(1 year)
- Quality of life - MINI MENTAL STATE(Base line and 6 months)
- Quality of Life - KPS(Base line and 6 months)
研究者
Dr Budhi Singh Yadav
Additional Professor
Post Graduate Institute of Medical Education and Research, Chandigarh