Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy

Study Overview
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Brief Summary
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The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

Official Title
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RECORA- Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy.

Conditions
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Colorectal Neoplasm

Intervention / Treatment
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* Drug: Regorafenib (Stivarga, BAY 73-4506)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:´ Male or female patients ≥ 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga. Patients must have signed an informed consent form Exclusion Criteria:

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 |
| --- | --- |
| Regorafenib<br>Patients treated with Stivarga as 3rd or 4th line treatment, no intervention | Drug: Regorafenib (Stivarga, BAY 73-4506)<br>* As determined by the treating physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | after 40 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | after 40 months | 
| Time to progression |  | after 40 months | 
| Disease control rate (DCR) | Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease). | after 40 months | 
| Duration of Stivarga treatment | Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation) | after 40 months | 
| Tumor status at different visits | The tumor status at different visits will be evaluated according to the categories complete response, partial response, stable disease, progressive disease by clinical judgment, progressive disease measurement proven, unknown and not applicable. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories. | after 40 months | 
| Incidence of treatment emergent adverse events (TEAE) | Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug. | after 18 and 40 months |