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

Study Overview
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Brief Summary
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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)

Detailed Description
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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).

Official Title
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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)

Conditions
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Metastatic Colorectal Cancer, RAS Wild-type

Intervention / Treatment
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* Drug: Panitumumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Any contraindication according to current SmPC Participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| low risk<br>Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) | Drug: Panitumumab<br>* Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.<br>* Other names: + FOLFIRI or FOLFOX;|
| medium risk<br>Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) | Drug: Panitumumab<br>* Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.<br>* Other names: + FOLFIRI or FOLFOX;|
| high risk<br>High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS) | Drug: Panitumumab<br>* Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.<br>* Other names: + FOLFIRI or FOLFOX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) of pre-defined risk groups low vs. high | 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. | From date of start of first line therapy to date of death due to any cause (assessed up to 84 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) of pre-defined risk groups low vs. intermediate | OS is defined as time from start of first line therapy to the date of death. | 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 | OS is defined as time from start of first line therapy to the date of death. | From date of start of first line therapy to date of death due to any cause (assessed up to 84 months) | 
| Overall Survival (OS) | OS is defined as time from start of first line therapy to the date of death. | 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) | 2-yrs OSR is defined as percentage of patients who are alive at 2 years after start of first line therapy. | at 24 months | 
| Progression-free Survival (PFS) | PFS is defined as time from start of first line therapy to first documentation of tumor progression or death due to any cause, whichever occurs first. | From date of start of first line therapy to date of progression or death due to any cause (assessed up to 84 months) | 
| 12-months PFS Rate (12-mos PFSR) | 2-yrs PFSR is defined as percentage of patients who are have not progressed or died due to any cause at 2 years after start of first line therapy. | at 12 months | 
| Overall Response Rate (ORR) | ORR is defined as percentage of patients who achieve a partial or complete response as best response during the treatment period. | From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months) | 
| Duration of Response (DoR) | DoR is defined as time from first documentation of any tumor response (≥ PR) until disease progression or death due to tumor progression. | From date of start of first line therapy to date of progression or death to any cause (assessed up to 84 months) | 
| Primary and secondary resection of metastases | Data on primary and/or secondary resections of liver or lung metastases will be collected. | From date of start of first line therapy to date of death due to any cause (assessed up to 84 months) | 
| Antineoplastic treatment in later lines | Treatment sequences with duration will be documented. | From date of start of first line therapy to date of death due to any cause (assessed up to 84 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mCRC, First line, Panitumumab, mCCS Prognostic Score, Prognosis, Ras wild type