NCT02035683进行中（未招募）不适用
Study of the Role of Metabolic Response Measured by PET/CT Scan After 1 Cycle of Chemotherapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)
National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
研究概览
简要总结
The purpose of this study is to test whether an early metabolic response, measured by PET/CT scan after the first cycle of chemotherapy, is able to predict which patients with advanced NSCLC have a better prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
- •Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
- •Both patients at first diagnosis or those with disease recurrence after initial surgery are eligible.
- •At least one target or non-target lesion according to RECIST revised version 1.
- •Age > or = 18 years .
- •ECOG PS 0-
- •Life expectancy > 3 months.
- •Signed informed consent.
排除标准
- •Uncontrolled diabetes (glucose > 200 mg/dl
- •EGFR mutation, for those patients who have had testing done. (EGFR test is not required for participation in the study, but may be conducted as part of normal clinical practice, and patients with EGFR mutation would not be candidate for first-line chemotherapy.)
- •Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
- •Pregnant or lactating females.
- •Previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry).
- •Any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol
- •Inability to provide informed consent.
结局指标
主要结局
change from baseline in highest value SUVmax (maximum standardized uptake values in PET/CT scan)
时间窗: one year
To validate as prognostic factor, in terms of overall survival,early metabolic response, defined as a reduction of more than 50% of the highest value of SUVmax recorded at PET/CT scan after one cycle of chemotherapy, compared to the highest value of SUVmax recorded baseline examination
次要结局
- objective response(3 months)
- Change from baseline in SUVmaxsum, TLGmax and TLGmaxsum(one year)
- overall survival(one year)
- correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with progression-free survival(one year)
- correlation among SUVmax, SUVmaxsum, TLGmax, TLGsum with objective response(3 months)
- progression free survival(12 months)
研究者
研究点 (1)
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