Phase III, Open, Multicenter and Randomized Study of Customized Adjuvant Chemotherapy Based on BRCA1 mRNA Levels in Completely Resected Stages II-IIIA Non-Small-Cell Lung Cancer Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 47
- 主要终点
- Estimated Overall Survival
研究概览
简要总结
Randomized Study of Customized Adjuvant Chemotherapy based on BRCA1 mRNA Levels in Completely Resected stages II-IIIA Non-Small-Cell Lung Cancer Patients.
详细描述
Randomized, phase III, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (NSCLC) after complete resection and with N1 or N2 involvement
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 with histological confirmation of non-small-cell lung carcinoma.
- •Complete surgical resection of the disease.
- •Tumoral tissue available for molecular analysis.
- •N1 (stage II) or N2 (stage IIIA) lymph node involvement in the study of the operative piece.
- •Men or women age 18 years or older.
- •Patients with a performance status of 2 or less according to the ECOG classification.
- •Patients with the following laboratory results: ANC < 1500/L, Hb < 10 g/dL, platelets <100,000/L, bilirubin < 1.0 mg/dL, AST and ALT < 1.5 upper limit of normality, creatinine clearance < 60 mL/min.
- •Complete recovery from surgery within 6 weeks.
- •Patients who have given written informed consent before initiating any specific study screening procedure.
排除标准
- •Patients who have received previously chemotherapy or radiotherapy for the study disease.
- •Impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances.
- •Patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator.
- •Women who are pregnant or in the period of lactation.
- •Patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma.
- •Patients under treatment with investigational agents.
研究组 & 干预措施
1 Control group
Control group:
*Docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both on day 1, every 21 days. Total cycles: Four.
干预措施: Docetaxel/Cisplatin control (Drug)
2 Experimental group
Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
- Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
- Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
- High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
干预措施: Docetaxel (Drug)
2 Experimental group
Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
- Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
- Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
- High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
干预措施: Gemcitabine/Cisplatin (Drug)
2 Experimental group
Experimental group, according to the BRAC1 levels of the tumor tissue, will be assigned one of the following treatments:
- Low expression of BRCA1 → gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4
- Intermediate expression levels of BRCA1 → docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total cycles: 4.
- High expression levels of BRCA1 → docetaxel 75 mg/m2, day 1. Cycles every 21 days. Total cycles: 4.
干预措施: Docetaxel/Cisplatin (Drug)
结局指标
主要结局
Estimated Overall Survival
时间窗: 5 years
To assess and compare the overall survival estimated at 5 years of both treatment groups (Control arm vs Experimental arm). Overall survival:The proportion of participants in treatment group who are still alive for a certain period of time after inclusion.
次要结局
- Disease Free Survival(5 years)