NCT01941654已完成2 期
A Single-arm Phase II Study to Determine the Efficacy of Preemptive Local Ablative Therapy to Residual Metabolic Active Oligo-metastases in Those EGFR Mutation Positive Non-small Cell Lung Cancer Patients Who Have Achieved a Good Partial Response With First-line EGFR TKI (ATOM)
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
- 18
- 试验地点
- 1
- 主要终点
- PFS rate at 1 year
研究概览
简要总结
To determine the efficacy of preemptive local ablative therapy in NSCLC patients with activating EGFR mutation who have oligometastatic residual metabolic-active disease after first-line EGFR TKI, as measured by PFS rate at 1 year from the trial enrollment.
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
- •Pathologically confirmed UICC 7th edition Stage IIIB (not amenable for curative intent local radiotherapy)/IV (metastatic or recurrent) non-small cell carcinoma of lung
- •Documented activating EGFR mutation (exon 19 deletion or exon 21 L858R only) in tumor tissues
- •Treated with first-line EGFR TKI for 3 months and achieved good radiological partial response that was documented with a CT scan
- •Not more than 4 residual metabolic active (SUVmax > 2.5) metastatic sites left on the screening PET-CT scan. (one bone metastatic site is regarded as a single site, mediastinal/ hilar lymph nodes in close proximity and possible to be treated in an acceptable volume is regarded as one lesion)
- •The shortest diameter of the lesion must be ≥ 1cm and is amenable to local ablative therapy
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •Age ≥ 18 years
- •Pleural or pericardial effusion at diagnosis is allowed only if it has resolved on CT scan after 3-month EGFR TKI treatment
- •Brain metastasis at diagnosis is allowed if it has been treated either surgically or with radiotherapy and there is no radiological progression on follow-up CT scan. The patient is neurologically stable for at least 1 week after cessation of steroid treatment
- •Adequate organ function as defined by the following criteria:
- •Serum alanine transaminase ≤ 3 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to liver metastases
- •Total bilirubin ≤ 1.5 x ULN
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- •Platelets count ≥ 100 x 109/L
- •Creatinine clearance > 45ml/min
- •Written informed consent that is consistent with ICH-GCP guidelines
排除标准
- •Prior chemotherapy is not allowed except adjuvant chemotherapy for completely resected early staged non-small cell lung cancer and it has been at least 12 months before the start of EGFR TKI treatment
- •Prior radiotherapy is not allowed except brain irradiation
- •Leptomeningeal carcinomatosis
- •Lymphangitis carcinomatosis of lung
- •Prior or concomitant malignancy at other sites is not allowed except treated non-metastatic non-melanoma skin cancer, ductal carcinoma-in-situ of breast and carcinoma-in-situ of cervix with curative intent
- •Uncontrolled active infection or medical condition (e.g. uncontrolled hypertension, unstable angina, congestive heart failure [≥ NYHA Class II], uncontrolled arrhythmia, myocardial infarction or cerebrovascular accident within the past 6 month)
- •Pre-existing interstitial lung disease
- •Woman of child-bearing potential or male patient is unwilling to use adequate birth control method prior to the study entry, for the duration of study participation and for at least 2 months after the EGFR TKI treatment has ended.
- •Pregnant and Lactating female patient
- •Non-compliance to the study procedure
研究组 & 干预措施
preemptive local ablative therapy
Experimental
干预措施: preemptive local ablative therapy (Radiation)
preemptive local ablative therapy
Experimental
干预措施: Oral TKI (Drug)
结局指标
主要结局
PFS rate at 1 year
时间窗: 2 years
次要结局
- Overall survival(2 years)
- radiologic change on PET-CT scan 3 months after SABR(3 months)
- Number of Participants with Adverse Events as a Measure of safety(2 years)
- Progression-free survival(2 years)
研究者
CCTU
Comprehensive Cancer Trials Unit
Chinese University of Hong Kong
研究点 (1)
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