Last updated on December 2018

Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix and FOLFIRI in First Line (VALIDATE)

Brief description of study

A safety and efficacy study of first line therapy with Vectibix in combination with irinotecan, 5fluorouracil, and folinic acid (FOLFIRI) to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting (VALIDATE)

Detailed Study Description

This is a non-interventional, prospective, open-label, single-arm, 3-cohort, multicenter study in Germany. In total, 1,240 patients will be enrolled in 100 oncological sites (office-based medical oncologists, oncology outpatient-centers, and university hospitals) in a time period of 36 months. Of these, 420 patients with high risk, 420 patients with intermediate risk, and 400 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 according to German regulations and current German SmPC. 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=620; 75 sites) 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 month after last patient in. The end of study will be at latest at 36 months after last patient in (LPI).

Clinical Study Identifier: NCT03043950

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Recruitment Status: Open

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