The Clinical Study of Personalized Therapy for Non-small Cell Lung Cancer Based on ERCC1/RRM1/TS Expression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The disease-free survival
研究概览
简要总结
Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively.
Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.
详细描述
Patients who had nonsmall- cell lung cancer (NSCLC) performance status of 0/1 were accrued to 2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy non-individuation ).
Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients accrued to Trial A were called the "personalized therapy" group. disease free survival (DFS) was estimated using the Kaplan-Meier method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（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
- •age from 18 years to 75 years
- •ECOG Performance Status no more than 2
- •at least one appraisable lung focus of diameter≥ 10 mm by lung CT
- •Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
- •Total bilirubin ≤1.5 x upper limit of normal (ULN)
- •ALT and AST < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
- •Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
- •Informed consent should be obtained before treatment.
排除标准
- •Mixed non-adenocarcinoma cell lung cancer histology
- •Previous treatment for Systemic chemotherapy or local radiotherapy
- •Be allergic to chemotherapy drugs
- •second active primary malignancy or serious concomitant medical disease
- •difficulties with adequate follow-up
研究组 & 干预措施
A.individual therapy
Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.
干预措施: carboplatin, gemcitabine , pametrexed (Drug)
B. non-individualized therapy
Carboplatin was administrated at an area under the plasma concentration time curve (AUC) of 5 on day 1 every 21 days, while gemcitabine was administrated at a dose of 1250 mg/m2 on day 1 and 8 and pemetrexed was administrated at a dose of 500 mg/m2 on day 1.
干预措施: carboplatin, gemcitabine , pametrexed (Drug)
结局指标
主要结局
The disease-free survival
时间窗: Followed up these patients for disease-free survival for 4 years
The disease-free survival was measured from the day of tumor resection until tumor recurrence (progression) or death as the end point
次要结局
未报告次要终点
研究者
Heyuwen
Yuwen He, MD
Guangzhou Medical University