RE-SEARCH Study: A Study to Learn How and in Which Amount Regorafenib is Given in Usual Practice to Patients in Spain: a Study Looking Back at Cases That Have Already Happened When the Study Begins.

Study Overview
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Brief Summary
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Researchers are collecting more information to improve treatment of metastatic colorectal cancer (mCRC) with regorafenib. Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel and involves the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is available to treat patients with mCRC that have previously been treated with, or are not considered candidates for, available therapies. It is an anti-cancer drug that blocks several proteins called enzymes which are involved in the growth of cancer. It is known that doctors may change the amount (the dose) of regorafenib they give, so that the patients better tolerate the treatment. Little information is however available on the doses of regorafenib given in Spain in usual practice. In this study researchers want to learn how and in which amount regorafenib is usually given to patients with mCRC in Spain. They aim to identify the starting dose of regorafenib and to describe dosing patterns during the first two four-week treatment periods (cycles) according to usual clinical practice. To answer these questions, the researchers will look back at cases that have already happened when the study begins. Medical history data from the day of diagnosis of the mCRC until the day prior to the inclusion in the study is collected from the medical records of adult patients with mCRC. All patients must have started their treatment with regorafenib since January 2017 and have taken regorafenib for at least 3 months. The researchers will collect the information between around June 2021 until around November 2021. The final report is planned to be available in July 2022. No investigational products will be administered in this study. Moreover, no additional visits or laboratory tests will be performed apart from the usual tests/treatments done in usual practice.

Official Title
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Dosing Patterns With Regorafenib in Clinical Practice in Spain: A Retrospective Study.

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient ≥ 18 years Patients with histological confirmation of mCRC Patient who started treatment with regorafenib for mCRC according to usual clinical practice during or after January 2017 and at least 3 months prior to the inclusion in the study Exclusion Criteria: Patient who have been treated with regorafenib during their participation in a clinical trial

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 |
| --- | --- |
| Metastatic colorectal cancer patients.<br>Medical history data of all patients with at least 1 treatment with regorafenib will be collected retrospectively. | Other: No intervention<br>* Retrospective analysis using database without any intervention assigned in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients that start regorafenib treatment with a dose of 80 mg. |  | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients that start regorafenib treatment with a dose of 120 mg |  | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients that start regorafenib treatment with a dose of 160 mg |  | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients that follow each dosing patterns during first two cycles of treatment |  | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median number of previous lines of treatment received for metastatic colorectal cancer (mCRC) at index. | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients according to number of previous lines received at index. | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Median time from mCRC diagnosis | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Median number of metastatic locations | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients with ECOG performance status at index | ECOG: Eastern Cooperative Oncology Group. | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients with comorbidities at index. | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients with mutated BRAF status at index | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients with mutated KRAS status at index. | At index (at regorafenib start date) | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Median duration of regorafenib treatment (cycles) | At follow-up | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Median progression free survival | At follow-up | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients for each reason of dose modification. | At follow-up | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 
| Percentage of patients that start cycle 3 based on dosing patterns. |  | Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Refractory metastatic colorectal cancer, Observational Study, Regorafenib