Standard Chemotherapy Strategy Versus Changing Chemotherapy Strategy as to FDG-PET Response After 1st Cycle of Standard Chemotherapy for Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- change in response rate
研究概览
简要总结
The usual response to chemotherapy is decided through the image change by computed tomography (CT), which is taken at least 6-9 weeks.
In order to predict the response to chemotherapy earlier, patients received FDG-PET scan at the first cycle of chemotherapy. Chemotherapy was guided by the metabolic response by FDG-PET scan.
详细描述
Prospective, Open-label, Randomized phase II, single institution trial that compared chemotherapy guided by traditional evaluation based on RECIST versus chemotherapy guided by FDG-PET (metabolic) response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Histologically confirmed non-small cell carcinoma.
- •Stage IIIB (wet) or IV advanced NSCLC.
- •No evidence of prior malignancies for 3 years except treated basal cell or squamous cell carcinoma of skin and carcinoma in situ of uterine cervix.
- •Measurable disease by RECIST criteria.
- •Adequate organ function as follows.
- •Seum AST/ALT < 2.5 x Upper normal limit (UNL) (if hepatic metastasis < 5 x UNL)
- •Total bilirubin < 1.5 x UNL
- •Serum creatinine < 1.5 mg/dL
- •Absolute neutrophil count > 1500/uL
- •Platelet > 100,000/uL
- •Hemoglobin > 9.0 g/dL
- •ECOG Performance status 0-1 7 Age > 18
- •If previously treated with major surgery, it should be over at least 4 weeks. And if previously treated with radiotherapy, it should be over at least 2 weeks.
- •Written consent
排除标准
- •Previous chemotherapy.
- •Symptomatic brain metastasis.
- •Concurrent severe medical illness.
- •Pregnancy and lactation.
- •If there are findings which may increase risk with chemotherapy or inhibit to analyze the result of clinical trial.
- •Uncontrolled diabetes mellitus.
研究组 & 干预措施
FDG-PET guided
Chemotherapy regimen will be changed depending on metabolic response.
干预措施: FDR-PET (Device)
CT guided
Chemotherapy regimen will be changed depending on CT findings (RECIST).
干预措施: CT (Device)
结局指标
主要结局
change in response rate
时间窗: within 4 cycles
The usual response rate of GenexolPM/Cisplatin chemotherapy is 30-40%. This trial will assess whether the changing chemotherapy strategy using FDG-PET can increase response rate by 15%.
次要结局
未报告次要终点