A Non-interventional Study to Assess the Safety and Efficacy of First Line Therapy With Vectibix® in Combination With FOLFIRI or FOLFOX and to Validate a Prognostic Score in Adult Patients With RAS Wild-type Metastatic Colorectal Cancer in a Real World Setting (VALIDATE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 647
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) of pre-defined risk groups low vs. high
研究概览
简要总结
A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting (VALIDATE)
详细描述
This is a non-interventional, prospective, open-label, single-arm, 3-cohort, multicenter study in Germany and Austria. In total, 606 patients will be enrolled in approx. 120 oncological sites (office-based medical oncologists, oncology outpatient-centers, and university hospitals) in a time period of 48 months. Of these, 202 patients with high risk, 202 patients with intermediate risk, and 202 patients with low risk, as a priori assessed by the metastatic colorectal cancer prognostic score (mCCS), will be included. Overall survival of the pre-defined prognostic groups will be analyzed as primary endpoint to validate the mCCS.
Patients have been scheduled to receive first line combination therapy with panitumumab and FOLFIRI or FOLFOX according to the current SmPC valid for Germany and Austria, respectively. Data on efficacy in terms of tumor response evaluation / survival and safety (ADRs) will be collected during first line therapy. A subset of patients participating in the 'VALIDATE-PRO' project (n=303) will be assessed for general and health-related quality of life with patient questionnaires. Biomarker status beyond RAS will be collected at baseline. The documentation of defined patient data including survival will continue until the end of the individual study participation which is latest 36 months after last patient in. The end of study will be at latest at 36 months after last patient in (LPI).
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
- •Eligibility according to current SmPC
- •Signed written informed consent
- •Diagnosis of RAS-WT mCRC
- •No prior systemic therapy in the palliative setting
- •Aged 18 years or older
排除标准
- •Any contraindication according to current SmPC
- •Participation in other clinical trials
研究组 & 干预措施
low risk
Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
干预措施: Panitumumab (Drug)
medium risk
Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
干预措施: Panitumumab (Drug)
high risk
High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)
干预措施: Panitumumab (Drug)
结局指标
主要结局
Overall Survival (OS) of pre-defined risk groups low vs. high
时间窗: From date of start of first line therapy to date of death due to any cause (assessed up to 84 months)
OS is defined as time from start of first line therapy to the date of death. For patients without date of start of first line therapy, date of informed consent will be the relevant date.
次要结局
- Primary and secondary resection of metastases(From date of start of first line therapy to date of death due to any cause (assessed up to 84 months))
- Overall Survival (OS) of pre-defined risk groups intermediate vs. high(From date of start of first line therapy to date of death due to any cause (assessed up to 84 months))
- 12-months PFS Rate (12-mos PFSR)(at 12 months)
- Duration of Response (DoR)(From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months))
- Antineoplastic treatment in later lines(From date of start of first line therapy to date of death due to any cause (assessed up to 84 months))
- Overall Response Rate (ORR)(From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months))
- Overall Survival (OS) of pre-defined risk groups low vs. intermediate(From date of start of first line therapy to date of death due to any cause (assessed up to 84 months))
- Overall Survival (OS)(From date of start of first line therapy to date of death due to any cause (assessed up to 84 months))
- 2-years OS Rate (2-yrs OSR)(at 24 months)
- Progression-free Survival (PFS)(From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months))