Randomized Phase II Study of Biweekly Chemotherapy With Gemcitabine and Carboplatin in Elder Patients With Previously Untreated 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
- 60
- 试验地点
- 1
- 主要终点
- Efficacy (response rate)
研究概览
简要总结
A comparison of biweekly combination chemotherapy (gemcitabine plus carboplatin) with weekly gemcitabine in elder patients (> 75) with previously untreated advanced non-small cell lung cancer. Primary objective is to determine the objective response rate (CR+PR by RECIST criteria) for biweekly gemcitabine and carboplatin combination chemotherapy versus weekly single gemcitabine as first-line therapy in elder advanced non-small lung cancer patients (> 76 years) who have received no prior treatment for non-small lung cancer. As secondary objectives, adverse event profile, tolerability of biweekly gemcitabine and carboplatin combination chemotherapy, progression-free survival and overall survival will be evaluated in both patients with biweekly gemcitabine and carboplatin combination chemotherapy and weekly single gemcitabine.
The study hypothesis is that biweekly combination chemotherapy of gemcitabine plus carboplatin may improve the efficacy.
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
- 76 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of histologically confirmed stage IIIB or IV non-small cell lung cancer
- •Good performance status (ECOG 0-1)
- •No previous treatment
- •Age 76 years and older
- •Adequate bone marrow, liver and renal functions
- •No pregnant
- •Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as >=1.0 cm by spiral CT scan
- •Provided written informed consent
排除标准
- •Severe complications or a concomitant malignancy
- •Prior and other concurrent radiotherapy, chemotherapy, immunotherapy, EGFR tyrosine kinase inhibitors
- •Interstitial pneumonia or lung fibrosis
- •Contraindicated gemcitabine or carboplatin
- •Inappropriate patients for entry to this study, judged by the physicians
研究组 & 干预措施
1
Gemcitabine 1000mg/m2 Day 1,15
Carboplatin AUC=3 Day 1, 15 every 4 weeks
干预措施: gemcitabine and carboplatin (Drug)
2
Gemcitabine 1000mg/m2 Day 1, 8, 15
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Efficacy (response rate)
时间窗: two-years, followed RECIST criteria
次要结局
- The toxicity profile (adverse event profile)(two-years, followed NCI-CTCAE criteria)
研究者
Naoki Inui
Department of Respiratory Medicine
Hamamatsu University