NCT01363557终止不适用
Randomized to Assess the Efficacy of Whole Brain Radiation Therapy (WBRT) With Concomitant Gefitinib Followed by Maintenance Gefitinib, and Gefitinib Alone, in Lung Cancer Patients With Brain Metastasis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To assess the objective response rate of brain metastases in each arm
研究概览
简要总结
Multicentre randomised (1:1) trial assessing the efficacy of whole brain radiotherapy in addition to Gefitinib for the management of brain metastasis in lung cancer patients with a mutated EGFR.
详细描述
Lung cancer patients with newly diagnosed CNS metastasis with- at least one brain lesion measuring > 1 cm in longest dimension - not eligible for surgery or stereotactic radio-surgeryOpen-label, multicentre, national, randomised (1:1) phase II trialArm A: WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance Arm B: Gefitinib
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have signed a written informed consent form prior to any study specific screening procedures
- •18 years or older
- •KPS ≥ 50%
- •Histologically confirmed adenocarcinoma of the lung
- •Activating mutation of EGFR
- •Newly diagnosed CNS metastasis or in progression with at least one measurable lesion in the brain (defined as any lesion > 1 cm on T1-weighted contrast enhanced MRI)
- •Patients could enter the study regardless of previous treatment (included chemotherapy) for metastatic extracranial disease, except TKI.
- •No steroids or stable or decreasing dose of steroids for at least 5 days before the MRI evaluation.
- •Adequate hematologic, liver and renal functions: neutrophil count ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; Hb ≥ 9 g/Dl; Total bilirubin < 1.5 x ULN; AST or ALT < 2.5 x ULN (< 5 x ULN in patients with liver metastases); Serum creatinine ≤ 1.5 x ULN or Creatinine clearance ≥ 50 mL/min
排除标准
- •Prior treatment of brain metastases with WBRT or TKI
- •Patient eligible for radiosurgery or surgical resection
- •Contre indication at the radiotherapy
- •Leptomeningeal disease
- •Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) within the the 5 years before study entry
- •Prior treatment with Gefitinib or other TKI
- •Pregnant or breast feeding women
- •Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective means of contraception
研究组 & 干预措施
Arm A : Gefitinib + WBRT
Experimental
Arm A : WBRT and Concurrent Gefitinib followed by Gefitinib Maintenance
干预措施: whole brain radiotherapy (Other)
Arm B : Gefitinib
Experimental
Arm B : Gefitinib alone
干预措施: Gefitinib (IRESSA) (Drug)
结局指标
主要结局
To assess the objective response rate of brain metastases in each arm
时间窗: at 6 weeks
次要结局
- Number of Participants with neurological Adverse Events(at 6 weeks, 3 months, 4.5 months and 6 months)
- Progression-free survival (PFS)(at 6 months)
- Overall survival(at 6 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Demonstrate the Safety of WBR Administered at the Same Time as Intrathecal Liposomal Cytarabine (DepoCyte®) Versus Intrathecal Liposomal Cytarabine (DepoCyte®) Administered After WBR for the Treatment of Solid Tumour Neoplastic Meningitis in Patients With or Without Brain Metastasis.Solid Tumour Neoplastic MeningitisBrain MetastasesNCT00854867Mundipharma Research Limited18
已完成
2 期
Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast CancerHER2-Positive Breast CarcinomaInvasive Breast CarcinomaMetastatic Malignant Neoplasm in the BrainRecurrent Breast CarcinomaStage IV Breast Cancer AJCC v6 and v7NCT01622868National Cancer Institute (NCI)143
已完成
3 期
Radiotherapy or Imiquimod in Complex Lentigo MalignaLentigo MalignaNCT02394132Melanoma and Skin Cancer Trials Limited126
尚未招募
不适用
A Multicenter Randomized Controlled Clinical Study on the Treatment of T3N1M0 High Risk Nasopharyngeal Carcinoma With or Without Induction Chemotherapy Before Concurrent Radiotherapy and ChemotherapyNasopharyngeal CarcinomaNCT05622474Sun Yat-sen University236
已完成
3 期
Whole Brain Radiotherapy following local treatment of melanoma brain metastasesMelanoma brain metastasesCancer - Malignant melanomaACTRN12607000512426Melanoma and Skin Cancer (MASC) Trials215