NCT01163305已完成不适用
Identifying an Early Indicator of Drug Efficacy in Patients With Advanced Colorectal Cancer - a Prospective Evaluation of Circulating Tumor Cells, Positron-emission Tomography Scan and RECIST Criteria
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy
研究概览
简要总结
The purpose of this study is to identify an early indicator of drug efficacy in patients with advanced colorectal cancer - a prospective evaluation of circulating tumor cells, positron-emission tomography scan and RECIST criteria.
详细描述
- To determine if measuring both tumor metabolic response (via FDG-PET scan) & circulating tumor cells (CirTC) at 4 weeks after starting treatment, is a better predictor of clinical outcome than measuring either modality alone in patients with metastatic colorectal cancer (CRC) who are undergoing first-line oxaliplatin-based chemotherapy.
- To determine if a new method of assessing drug response (measuring tumor metabolic response via FDG-PET & CirTC at 4 weeks after starting treatment) better predicts clinical outcome than the conventional method (measuring radiological changes in tumor dimensions at 10 weeks after starting treatment via the 'Response Evaluation Criteria in Solid Tumors' - RECIST).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Metastatic colorectal cancer patients not received prior drug treatment for metastatic CRC
- •Age >= 18 years
- •(ECOG) performance status of 0-2
- •Measurable tumor sites by RECIST criteria
- •Adequate bone marrow, renal & hepatic functions
排除标准
- •Patients with diabetes mellitus
- •presence of hyperglycemia
- •Pregnant or lactating patients
研究组 & 干预措施
metastatic colorectal cancer
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Tumor metabolic response via FDG-PET at 4 weeks after chemotherapy
时间窗: 2 years
次要结局
- Progression-free survival(4 years)
- Circulating tumor cells level changes at 4 weeks after chemotherapy(2 years)
- serum carcinoembryonic antigen (CEA) level(4 years)
- Overall survival(4 years)
- RECIST-based tumor response at 10 weeks after chemotherapy(2 years)
研究者
CCTU
Prof. Brigette Ma
Chinese University of Hong Kong
研究点 (1)
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