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临床试验/CTRI/2015/10/006268
CTRI/2015/10/006268招募中2 期

Study to evaluate the feasibility of response adapted whole brain radiotherapy after methotrexate based chemotherapy in patients of newly diagnosed primary CNS lymphoma

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年7月15日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
20
试验地点
1
主要终点
Response rate, Progression free survival

研究概览

简要总结

The primary objective of the study is toevaluate the feasibility of response adapted whole brain radiation therapy after methotrexate based chemotherapy in immunocompetent patients of newly diagnosed primary central nervous system (CNS) lymphoma. The secondary objectives are

1.      To assess Epstein-Barr Virus (EBV) positivity and molecular subtype of lymphoma and their correlation with treatment outcome

  1. To assess the toxicity profile, neurocognitive effects of  treatment and serial changes in quality of life in  patients of primary central nervous system lymphoma

The reduced dose whole brain radiotherapy in patients with complete response after methotrexate based polychemotherapy has yielded excellent outcomes in foreign studies. This kind of study has not been conducted in Indian context. This will benefit the complete responders of chemotherapy by reducing treatment related neurotoxicity thus improve quality of life in the patients of Primary CNS lymphoma without compromising disease control. We are also correlating EBV positivity, molecular subtyping with treatment outcomes which may open further doors of research for personalised treatment and novel therapies. We will be doing neurocognitive assessment using the neuropsychological test battery designed for Indian context according to international recommendations so it will effectively assess the treatment related neurotoxicity in Indian patients who are educationally, socioeconomically and linguistically different from Western population.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Newly diagnosed, not received any treatment for primary cns lymphoma previously, with performance status(PS) ECOG 0-3, biopsy proven disease, immunocompetent.

排除标准

  • Any comorbidity that compromises chemo-radiotherapy treatment.

结局指标

主要结局

Response rate, Progression free survival

时间窗: 6 months, 2 years

次要结局

  • Overall survival, toxiciy profile, Neuropsychological profile, Pathological correlation with treatment outcomes(2 years)

研究者

申办方类型
Government medical college

研究点 (1)

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