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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

647 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-25

Study Completion Date

2024-01-17

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)

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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).

Conditions

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Metastatic Colorectal Cancer RAS Wild-type

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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low risk

Low risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Panitumumab

Intervention Type DRUG

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.

medium risk

Medium risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Panitumumab

Intervention Type DRUG

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.

high risk

High risk according to metastatic Colorectal Cancer Prognostic Score (mCCS)

Panitumumab

Intervention Type DRUG

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.

Interventions

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Panitumumab

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.

Intervention Type DRUG

Other Intervention Names

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+ FOLFIRI or FOLFOX

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