NCT01518621终止2 期
Whole Brain Radiation With or Without Erlotinib for Brain Metastases From Non-Small Cell Lung Cancer
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
To determine if erlotinib given orally along with concurrent whole brain irradiation in lung cancer patients with brain metastases improves median overall survival and enhances local control compared to those treated with WBRT alone, without significantly increasing the risk of side effects or lowering quality of life.
详细描述
Endpoints
Primary:
• To determine if erlotinib given orally along with concurrent WBRT in lung cancer patients with brain metastases, improves median overall survival compared to those treated with WBRT alone.
Secondary:
- To confirm the safety profile of erlotinib along with concurrent WBRT, in the context of treating central nervous system malignancies.
- To evaluate if erlotinib along with concurrent WBRT increases local control rate as measured by MRI at 8 weeks, compared to WBRT alone.
- To evaluate if erlotinib along with concurrent WBRT increases time to neurologic progression of disease based on neuropsychological assessment at baseline, at 8 and 20 weeks after WBRT.
- To evaluate quality of life parameters in patients treated with WBRT alone vs concomitant erlotinib and WBRT
- To evaluate if mutation status has impact on the above mentioned parameters Trial design Open multicenter randomized phase II trial. Patients Patients > 18 years with histologically confirmed NSCLC and brain metastases verified on either CT or MRI, not eligible for neurosurgery or stereotactic radiation therapy.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
- •Newly diagnosed multiple brain metastases not suitable for first-line chemotherapy
- •Relapsed NSCLC with newly diagnosed multiple brain metastases
- •Relapsed NSCLC after second-line or more chemotherapy regimens with newly diagnosed multiple brain metastases
- •Diagnosis of brain metastases confirmed by MRI (or CT if MRI is not available/possible) within the past 4 weeks
- •Symptoms attributable to brain metastases
- •Patients who have undergone craniotomy with incomplete resection are eligible
- •Clinician's opinion that whole-brain radiotherapy (WBRT) will be beneficial
- •ECOG PS 0-2
- •Age above 18 years
- •Serum bilirubin < 2 times upper limit of normal (ULN)
- •AST and ALT < 2 times ULN (< 5 times ULN if liver metastases are present)
- •Creatinine < 1.5 times ULN
- •Able to take oral medication
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other prior or concurrent malignant disease likely to interfere with study treatment or comparisons
排除标准
- •More than 3 sites (organ systems) of extracranial metastases
- •Evidence of solitary brain metastasis on MRI that can be treated with surgical resection, radiosurgery, or stereotactic radiotherapy
- •Evidence of other significant laboratory finding or concurrent uncontrolled medical illness, that in the opinion of the investigator, would interfere with study treatment or results comparison or render the patient at high risk for treatment complications
研究组 & 干预措施
Radiotherapy alone
Active Comparator
Total brain irradiation, 3Gy x10
干预措施: Radiation (Radiation)
Radiation plus erlotinib
Experimental
Total brain irradiation, 3Gy x10 plus erlotinib 150 mg q d from radiation day -1 through last day of irradiation
干预措施: Radiation plus erlotinib (Drug)
研究者
Odd Terje Brustugun
Senior consultant
Oslo University Hospital
研究点 (1)
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