NCT00268684Unknown3 期
A Phase III Trial Comparing Whole Brain Radiation (WBRT) and Stereotactic Radiosurgery (SRS) Alone Versus With Temozolomide or Erlotinib in Patients With Non-Small Cell Lung Cancer and 1-3 Brain Metastases
适应症
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 381
- 试验地点
- 2
- 主要终点
- survival
研究概览
简要总结
The objectives of the study is to determine if either temozolomide or erlotinib combined with WBRT and SRS improves survival as compared to WBRT and SRS alone.Ptients with histologically confirmed NSCLC with the presence of 1-3 intraparenchymal brain metastases will be randomized to 3 arms. All of the patients will receive WBRT and SRS. The patients of the arm 1 will receive radiation treatment only, the arm 2 patients will be treated with temozolomide and arm 3 patients will receive erlotinib
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed non-small cell lung cancer with the presence of 1-3 intraparenchymal brain metastases.
- •A contrast-enhanced MRI demonstrating the presence of 1-3 brain metastases performed within two weeks prior to registration.
- •The contrast-enhancing intraparenchymal brain tumor must be well circumscribed and must have a maximum diameter of ≤ 4.0 cm in any direction on the enhanced scan. If multiple lesions are present and one lesion is at the maximum diameter, the other(s) must not exceed 3.0 cm in maximum diameter.
- •Patients who present with symptoms of brain metastases at the time of initial diagnosis are eligible and do not need to demonstrate one month of stable scans.
- •Age 18 years or older.
- •Neurologic Function Status 0, 1, or
- •Patients may have stable extracranial metastases.
- •Contrast-enhancing CT scans of the chest, abdomen and pelvis, and bone scan to determine the extent of extracranial malignant disease.
- •Adequate bone marrow reserve
- •Patients randomized to receive erlotinib who are on enzyme inducing seizure medicines including phenytoin, carbamazepine, rifampicin, barbiturates must be converted to a nonenzyme inducing anti-seizure medication. Patients on Arm 3 will not be able to start treatment immediately if converting.
- •Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
排除标准
- •Major medical illnesses or psychiatric impairment
- •Patients who have undergone a complete resection of all known brain metastases.Patients who have undergone subtotal resection are eligible providing residual disease is =/< 4.0 cm in maximum diameter.
- •Inability to obtain histologic proof of NSCLC.
- •Patients with leptomeningeal metastases documented by MRI or CSF evaluation.
- •Clinical or radiographic evidence of progression (other than the study lesion(s)) within one month prior to enrollment. (Patients who have brain metastases at initial presentation are eligible and do not need to demonstrate one month of stable scans).
- •Patients with metastases within 10 mm of the optic apparatus so that some portion of the optic nerve or chiasm would be included in the high dose SRS boost field.
- •Patients with metastases in the brainstem, midbrain, pons, or medulla.
- •Patients with liver metastases.
- •Previous cranial radiation.
- •Women who are pregnant or nursing
- •Patients who are HIV positive are not eligible.
- •Any evidence of clinically active interstitial lung disease
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of studytreatment.
- •Concomitant use of St. John's Wort.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib and temozolomide.
结局指标
主要结局
survival
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Phase Ⅲ Trial of WBRT Versus Erlotinib Concurrent Whole-brain Radiation Therapy as first-line Treatment for Patients With Multiple Brain Metastases From Non-small-cell Lung Cancer(ENTER): a Multicentre, Open-label, Randomised StudyMultiple Brain MetastasesNon-small-cell Lung CancerNCT01887795Daping Hospital and the Research Institute of Surgery of the Third Military Medical University224
已完成
2 期
Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With GlioblastomaGlioblastoma With Primitive Neuronal ComponentGliosarcomaGlioblastomaMalignant GliomaOligodendroglial Component PresentNCT03746080Lawrence D Recht21
Unknown
1 期
Temozolomide and Concomitant Whole Brain Radiotherapy in NSCLC Patients With Brain MetastasesNSCLCNCT02385136Zhejiang Cancer Hospital135
终止
3 期
Radiation Therapy and Stereotactic Radiosurgery With or Without Temozolomide or Erlotinib in Treating Patients With Brain Metastases Secondary to Non-Small Cell Lung CancerMetastatic Malignant Neoplasm in the BrainRecurrent Non-Small Cell Lung CarcinomaStage IV Non-Small Cell Lung Cancer AJCC v7NCT00096265National Cancer Institute (NCI)126
已完成
3 期
Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed GlioblastomaGliosarcomaSupratentorial GlioblastomaGlioblastomaNCT00884741National Cancer Institute (NCI)637