Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Response rate (complete and partial responses)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating non-small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing different combination chemotherapy regimens to see how well they work as first-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
- To assess treatment outcomes of adjuvant chemotherapy based on ERCC1 and RRM1 mRNA levels in patients with stage IIIB or IV non-small cell lung cancer.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
RNA is isolated from pretreatment biopsy samples and analyzed with reverse transcriptase-PCR (RT-PCR) assays to determine ERCC1 and RRM1 mRNA expression.
- Arm I: Patients receive standard chemotherapy comprising docetaxel IV and carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients are treated according to ERCC1 and RRM1 mRNA expression levels as determined by RT-PCR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive standard chemotherapy of docetaxel and carboplatin.
干预措施: carboplatin (Drug)
Arm I
Patients receive standard chemotherapy of docetaxel and carboplatin.
干预措施: docetaxel (Drug)
Arm II, Genotype A1
Patients receive docetaxel and vinorelbine ditartrate.
干预措施: docetaxel (Drug)
Arm II, Genotype A1
Patients receive docetaxel and vinorelbine ditartrate.
干预措施: vinorelbine tartrate (Drug)
Arm II, Genotype A2
Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
干预措施: gemcitabine hydrochloride (Drug)
Arm II, Genotype A2
Patients receive gemcitabine hydrochloride and vinorelbine ditartrate.
干预措施: vinorelbine tartrate (Drug)
Arm II, Genotype B1
Patients receive docetaxel and carboplatin.
干预措施: carboplatin (Drug)
Arm II, Genotype B1
Patients receive docetaxel and carboplatin.
干预措施: docetaxel (Drug)
Arm II, Genotype B2
Patients receive gemcitabine hydrochloride and carboplatin.
干预措施: carboplatin (Drug)
Arm II, Genotype B2
Patients receive gemcitabine hydrochloride and carboplatin.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Response rate (complete and partial responses)
次要结局
- Disease control rate
- Response duration
- Progression-free survival
- Overall survival
- Toxicity