Prospective randomized study to evaluate the impact of radiotherapy and radiotherapy technique on neurocognitive profile in grade 2 and 3 gliomas.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in neurocognitive function
研究概览
简要总结
Patients who need adjuvant chemoradiation after surgical intervention for lower grade gliomas would be assessed for neurocognitive function before radiotherapy and its change longitudinally after therapy. We aim to evaluate if radiotherapy causes neurocognitive change, quantify the change and to assess if more conformal radiotherapy techniques such as VMAT with hippocampal avoidance have a difference profile of neurocognitive function compared to patients treated with 3DCRT without hippocampal avoidance. Also, we will assess the quality of life in this group of patients longitudinally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with infiltrative lower grade gliomas (grade 2-3) who have undergone tumor removal or at least biopsy with histopathologic confirmation.
- •2.Cranial radiotherapy is clinically indicated to prevent recurrence due to presence of high risk features (astrocytoma histology), subtotal resection (STR) or age older than 40 years.
- •3.Karnofsky Performance Status Scale score (KPS) more than or equal to
- •4.No prior history of radiation to the brain.
- •5.No contraindications to contrast enhanced computed tomography (CECT) and contrast enhanced magnetic resonance imaging (CEMRI).
- •6.Routine blood parameters (Complete blood count (CBC), liver function test (LFT), kidney function test (KFT)) within normal limits.
- •7.Willing to give consent for the study.
排除标准
- •Any non malignant known CNS disease that can cause neurocognitive dysfunction.
- •Pregnant and lactating women.
- •Prior long term chemotherapy.
- •Moderate or severe neurocognitive dysfunction prior to radiotherapy (MMSE less than or equal to 18).
结局指标
主要结局
Change in neurocognitive function
时间窗: pre radiotherapy treatment | post radiotherapy treatment | 3 months after radiotherapy treatment | 6 months after radiotherapy treatment
次要结局
- Change in Quality of life(Before radiotherapy treatment)
- Change in Depression, Anxiety & Stress Scale - 21 Items (DASS-21).(Before radiotherapy treatment)
研究者
Dr Aditya Mehta
Post Graduate Institute of Medical Education and Research, (PGIMER), CHANDIGARH