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临床试验/NCT03732482
NCT03732482Unknown2 期

A Phase II/III Study of Non Small Cell Lung Cancer Patient With/Without Synchronous Oral Temozolomide Capsules Combine With Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost With Hippocampus Protection

Taizhou Hospital0 个研究点目标入组 400 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
400
主要终点
OS

研究概览

简要总结

With the improvement of systemic therapeutic effect(especially in the population with driver gene mutation), the incidence of brain metastases had significantly increased. Conventional Whole Brain radiotherapy(WBRT) was less effective, the stereotactic radiosurgery(SRS) technique had improve the local efficacy for 1-3 lesions, but the probability of intracranial recurrence was increased, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost(SIB-IMRT) is a new radiotherapy technology, Giving a standard radiation dose of whole brain ,at the same time can boost the high-risk region in target, So that it can significantly shorten the treatment time, at the same time can improve the local control rate of brain metastases. In the aspect of normal tissue protecting, SIB was better than WBRT plus SRS sequential treatment pattern. 30Gy to the whole brain had a negative effects on cognitive function, the investigators previous study found that 25Gy to the whole brain while the tumor bed Simultaneous push to 50Gy was safe and effective, while reducing the impact on cognitive function. Hippocampus is a part of the brain located in the temporal lobe, Mainly responsible for long-term memory storage conversion and orientation. Many investigators point out that hippocampus is the main commander of neurocognitive function, Reduce the dose of hippocampus can significant improve the neurocognitive function. Temozolomide capsule is an anti-tumor alkylation agent for glioblastoma multiforme and anaplastic astrocytoma. In recent years, some researchers find that Temozolomide capsules combine with radiotherapy such as SRS, WBRT or The two combined, can improve Objective response(OR) and prolong the Progress Free Survival(PFS),while with tolerable therapeutic toxicity. In order to better reduce the impact on cognitive function and improve the local control rate, the investigators present this trial, under the SIB-IMRT technique, the investigators want to explore the effect of temozolomide in brain metastasis of non-small cell lung cancer with the hippocampal protection technology.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients must have an estimated survival of at least 4 weeks
  • Karnofsky Performance Status Scale (KPS) of 60-
  • Patients' laboratory values had to meet these restrictions: hemoglobin>8 g/dL, platelets>70*109/L, white blood cells>4*109/L.
  • Patients must sign a study specific informed consent form prior to study entry

排除标准

  • Patients had major medical illnesses or psychiatric impairments which will prevent completion of the protocol therapy
  • had received previous brain irradiation
  • could not be regularly followed
  • with leptomeningeal involvement

研究组 & 干预措施

RT groups

Placebo Comparator

participants was given radiotherapy only,50Gy in 10 fractions over 2 weeks to metastases synchronously with 25Gy WBRT

干预措施: radiotherapy (Device)

Drug plus RT groups

Experimental

Temozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy.

干预措施: Temozolomide capsules (Drug)

结局指标

主要结局

OS

时间窗: Duration of time from the start of therapy 3 years or until time of death, whichever occurs first

overall survival

次要结局

  • iPFS(Duration of time from the start of therapy to the time of intracranial disease progression, assessed up to 3 years)
  • overall response rate(Up to 1 month)
  • MMSE scores(up to 2 years)

研究者

发起方
Taizhou Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haihua Yang

head of department of Radiation Oncology,chief physician,

Taizhou Hospital

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