Comparison of Response and Dosimetry between Sequential Boost and Simultaneous Integrated Boost (with two different dose schedules) in Radiotherapy for High Grade Gliomas
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare response assessment, toxicity profiles, OS, PFS, dosimetric analysis and neurocognitive function in patients receiving Sequential Boost and Simultaneous Integrated Boost Radiotherapy (with two different dose schedules) in High Grade Gliomas
研究概览
简要总结
High-grade gliomas account for approximately 59% of all primary brain tumors in adults in India. They are rapidly growing tumors that directly invade the brain parenchyma but almost never metastasize outside the CNS. They present in any age group, although most occur in late adulthood. GBM accounts for approximately 75% of all high-grade gliomas. Treatment for high grade gliomas involve a multidisciplinary approach which include neurosurgeons, radiation oncologists, physicists and medical oncologists. However, high grade gliomas carry poor prognosis with standard treatments, due to the nature of disease and its close proximity to vital structure in the central nervous system.
This will be a single institutional, prospective, interventional study. Eligible patients
of high grade gliomas will undergo proper clinical examination, laboratory
and imaging investigations. Three simultaneous radiation treatment plans will be generated, one of Sequential Boost and two of Simultaneous Integrated Boost RT. At the end of treatment planning, all the plans would be compared in terms of Planning Total Volume coverage, sparing of Organs At Risk, Homogeneity Index and Conformity Index. Patients would be followed up for response assessment, toxicity profiles, OS, PFS, and neurocognitive function.
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
- All
入选标准
- •All patients of biopsy proven non metastatic high grade glioma
- •ECOG Performance Status 0 to
- •Normal baseline hematological and biochemical parameters
- •Patients willing to provide informed consent with signature or left thumb impression for the approval for inclusion in the study.
排除标准
- •Evidence of distant metastasis by clinical or radiographic means.
- •Prior Radiotherapy
- •History of prior malignancy.
- •Pre-existing uncontrolled co-morbid medical conditions like Diabetes mellitus, cardiac ailments, neurological ailments for which deviation from oncological treatment protocol is required.
- •Patient refusal to undergo radiation.
- •Pregnancy or Lactation.
- •Other synchronous or metachronous primary malignancy.
- •Allergy to iodinated IV contrast or gadolinium.
结局指标
主要结局
To compare response assessment, toxicity profiles, OS, PFS, dosimetric analysis and neurocognitive function in patients receiving Sequential Boost and Simultaneous Integrated Boost Radiotherapy (with two different dose schedules) in High Grade Gliomas
时间窗: 24months
次要结局
未报告次要终点
研究者
Dr Shatarupa Chattopadhyay
R G Kar Medical College and Hospital, Kolkata