NCT01573702已完成2 期
Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Percentage of Participants With Progression Free Survival
研究概览
简要总结
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
详细描述
Primary Objectives
- To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Secondary Objectives
- To evaluate local control of sites previously progressive on erlotinib following stereotactic radiosurgery (SRS) followed by erlotinib
- To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
- To characterize the toxicity of SRS
- To characterize the toxicity of erlotinib when preceded by SRS
Exploratory Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Written informed consent
- •18 years of age or older
- •Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
- •History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
- •Progressive disease following EGFR-TKI therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate organ and marrow function
- •Negative urine or serum pregnancy test for female patients
- •Patients who can have children must agree to adequate contraception
排除标准
- •Unresolved chronic toxicities greater than 2, measured by CTCAE v4
- •Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
- •Any history of previous greater than grade 3 toxicity attributable to erlotinib
- •Pregnant or lactating female
- •Any previous radiation to sites of planned Stereostatic Radiosurgery
- •History of another malignancy
- •Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
- •Evidence of severe or uncontrolled systemic diseases
- •Known hypersensitivity reaction or idiosyncrasy to erlotinib
- •Psychological, familial, sociological, or geographical conditions
- •Any other condition in investigator's opinion jeopardize compliance with protocol
研究组 & 干预措施
Stereotactic Radiosurgery Followed by Erlotinib
Other
Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
干预措施: Stereotactic Radiosurgery (Procedure)
Stereotactic Radiosurgery Followed by Erlotinib
Other
Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
干预措施: Erlotinib (Drug)
结局指标
主要结局
Percentage of Participants With Progression Free Survival
时间窗: 3 months after Initiation of Stereostatic Radiotherapy
Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-tyrosine kinase inhibitor (TKI) therapy reported as percentage of participants who are alive and without progressive disease at 3 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.
次要结局
- Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS)(Initiation of Stereotactic Radiotherapy every 6 to 12 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Median Overall Survival(up to 5 years after end of treatment)
- Toxicity Rate From Stereotactic Radiosurgery (SRS)(From initiation to the end of SRS, up to 15 days)
- Toxicity Rate Attributed to Erlotinib(from end of SRS to end of erlotinib treatment (median duration of 5.7 months))
研究者
研究点 (8)
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