Randomized Phase II Trial: Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker.
研究概览
简要总结
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
详细描述
Purpose:
This randomized phase II trial evaluated whether the combination of cisplatin and paclitaxel plus All-trans retinoic acid (ATRA) increases Response rate (RR) and Progression-free survival (PFS) in patients with advanced Non-small cell lung cancer (NSCLC) with an acceptable toxicity profile and its association with the expression of Retinoic acid receptor beta 2 (RAR-beta2 ) as a response biomarker.
Patients and Methods:
Patients with stage IIIB and IV NSCLC were included to receive Paclitaxel and Cisplatin (PC). Patients were randomized to receive ATRA 20 mg/m2/day (RA/PC) or placebo (P/PC) 1 week prior to treatment until completing two cycles. RAR-beta2 expression was analyzed by Immunohistochemistry (IHC) and RT-PCR in tumor and adjacent lung tissue.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stage III B and IV NSCLC
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •No prior cytotoxic chemotherapy for NSCLC
- •Age ≥18 years, adequate laboratory measurements
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
- •Life expectancy of >12 weeks.
排除标准
- •Patients who had received prior chemotherapy
- •Patients with other comorbid conditions
研究组 & 干预措施
P/PC arm
Patients were assigned to receive placebo (P/PC) 1 week prior to treatment until completing two cycles
干预措施: PLACEBO (Other)
RA/PC arm
Patients were assigned to receive ATRA 20 mg/m2/day (RA/PC) 1 week prior to treatment until completing two cycles
干预措施: ATRA (Drug)
结局指标
主要结局
The primary end-point was Response rate (RR) and Progression-free survival (PFS), as well as identifying whether expression of RAR-beta2 is a response biomarker.
时间窗: 2 years
次要结局
- Evaluate the efficiency and safety of low doses of ATRA in patients with advanced NSCLC who receive first-line CT.(2 years)