NCT00828620终止不适用
Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- PET response on day 7
研究概览
简要总结
Molecular imaging with positron emission tomography (PET) using [18F] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Histologically or cytologically proven colorectal cancer
- •Unresectable stage IV disease
- •K-Ras wild type tumour
- •Patients scheduled to undergo chemotherapy with irinotecan and cetuximab
排除标准
- •Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study
- •Poorly controlled diabetes
- •Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection
- •Symptomatic brain metastases
- •Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception
结局指标
主要结局
PET response on day 7
时间窗: day 7
次要结局
- To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6(week 6)
- To define the optimal cutoff value of SUVmax and their predictive value(at day 7 and week 6)
- To explore the test/retest reliability of PET/CT in this setting(2 weeks)
- To assess the value of PET/CT at day 7 in predicting overall survival(up to 1 year)
- To asses the correlations between biomarkers and PET changes after Cetuximab(up to 6 months)
研究者
研究点 (6)
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