Factors Impacting on Efficacy and Compliance to Cetuximab Treatment in First Line WT KRAS Metastatic Colorectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
研究概览
简要总结
PREMIUM is an observational pharmaco-epidemiologic, transversal, multi-centric, prospective cohort study and with independent investigators. The purpose is to compare PFS in real life with PFS clinical trials and to determine factors impacting efficacy and compliance to cetuximab treatment in first line K-ras wild-type (wt) metastatic colorectal cancer.
详细描述
Retrospective studies have shown the influence of some factors on the efficacy of treatment with cetuximab (nicotine, magnesium etc..). No randomized study has compared the mode of administration of weekly and biweekly cetuximab. What are the factors influencing patient compliance? Adverse events, the relation between doctor and patient. PREMIUM will attempt to explore and assess the variables associated with efficacy and compliance to treatment and study practices in France for clinical management.
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
- •patients > 18 years old diagnosed with mCRC
- •patients naïve for CT excepted for adjuvant setting or trated max 2 cycles CT in first line mCRC with or without cetuximab
- •all patients receiving cetuximab in first line treatment associated or not with CT
- •patients relapsed < 6 months after an adjuvant therapy
排除标准
- •patients participating to clinical trials
结局指标
主要结局
To compare PFS rate at 1 year with PFS in clinical studies (ITT and subgroup analysis)
时间窗: 3 years
次要结局
- ORR at 1 year (ITT and subgroup analysis)(3 years)
研究者
Dr.Laurent Mineur
Oncologist
Institut Sainte Catherine