A Phase II Multi-center Pilot Study of Concurrent Temozolomide and Whole Brain Irradiation in Lung Cancer and Breast Cancer Patients With Brain Metastases
2014年5月6日 更新者：Far Eastern Memorial Hospital
A Phase II, Open-label, Single-arm, Multi-center Pilot Study to Evaluate the Efficacy and Safety of Whole-brain Radiotherapy With Concomitant Temozolomide in Lung Cancer and Breast Cancer Patients With Brain Metastases
Brain metastasis (BM) is among the most feared complications in cancer because even small tumors may cause incapacitating neurologic symptoms.
It is observed in more than 50% of patients with lung cancer and 15% to 25% of patients with breast cancer.
Temozolomide (TMZ) is an oral alkylating agent that crosses blood-brain barrier (BBB).
This pilot study aims to evaluate the efficacy, safety and tolerability of whole-brain radiotherapy (WBRT) plus concomitant TMZ in lung cancer and breast cancer patients with BM.
研究概览
研究类型
介入性
注册 (预期的)
24
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Taipei City、台湾、220
- Far Eastern Memorial Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Histologically or cytologically confirmed lung cancer or breast cancer at primary site
- Patient with inoperable brain metastases
- Female or male, ≥ 20 and < 65 years of age
- Karnofsky performance status (KPS) ≥ 70%
- Life expectancy ≥ 12 weeks
- Adequate organ function
- Willing and able to provide a written informed consent
Exclusion Criteria:
- Female of childbearing potential* who is pregnant/lactating or planning to be pregnant
- Male whose partner is planning to be pregnant
- Inability to swallow
- Meningeal carcinomatosis
- History of hypersensitivity to iodinated contrast media, temozolomide or any component of the study drugs
- Prior use of temozolomide
- Use of systemic chemotherapy within 2 weeks prior to the initiation of study treatment
- Prior surgery, chemotherapy or radiotherapy for a brain neoplasm
- Current use of valproic acid
- Use of any investigational product within 4 weeks prior to the initiation of study treatment
- Patient with any condition or disease which is considered not suitable for this study by investigator
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：temozolomide+WBRT
temozolomide: TMZ 200 mg p.o. q.d.
x 5 days per week x 3 weeks WBRT:30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week)
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WBRT: 30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week) CT: TMZ 200 mg p.o. q.d.
x 5 days per week x 3 weeks
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
objective response rate (ORR)
大体时间：assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
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To evaluate the objective response rate (ORR) of WBRT plus concomitant TMZ treatment in lung cancer and breast cancer patients with BM.
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assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression free survival (PFS)
大体时间：assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
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Progression free survival (PFS), Overall survival (OS), Change from baseline in MMSE scores, Change from baseline in SF-36
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assessments will be conducted between 10 to 14 weeks after the end of treatment, all subjects will be followed every 3 months since Month 6 until completion of study (12 months after the last patient is enrolled) or death, whichever comes first.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety
大体时间：safety of study treatments will be assessed by physician at each return. The safety for individual subject will be followed till 2 weeks after EOT.
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safety of study treatments will be assessed by physician at each return. The safety for individual subject will be followed till 2 weeks after EOT.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Pei-Wei Shueng, MD、Chief, Department of Radiation Oncology
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年5月1日
初级完成 (预期的)
2015年5月1日
研究完成 (预期的)
2016年5月1日
研究注册日期
首次提交
2014年2月5日
首先提交符合 QC 标准的
2014年5月6日
首次发布 (估计)
2014年5月8日
研究记录更新
最后更新发布 (估计)
2014年5月8日
上次提交的符合 QC 标准的更新
2014年5月6日
最后验证
2014年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.