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.

NCT04920422 | Completed

• 1 other identifier: 21749
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer

Keywords

Colorectal cancer; Refractory metastatic colorectal cancer; Observational Study; Regorafenib

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Median number of previous lines of treatment received for metastatic colorectal cancer (mCRC) at index.

  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.

  Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study.

• Median time from mCRC diagnosis

  Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study.

• Median number of metastatic locations

  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

  Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study.

Study Arms (1)

Metastatic colorectal cancer patients.

Medical history data of all patients with at least 1 treatment with regorafenib will be collected retrospectively.

Other: No intervention

Interventions

No intervention OTHER

Retrospective analysis using database without any intervention assigned in the study.

Metastatic colorectal cancer patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spanish participants will be included in this study if they had at least one dose of regorafenib in past treatment cycle.

You may qualify if:

• Patient ≥ 18 years
• Patients with histological confirmation of mCRC

You may not qualify if:

• Patient who have been treated with regorafenib during their participation in a clinical trial

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, Spain

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: July 15, 2021
• Primary Completion: October 7, 2022
• Study Completion: October 7, 2022
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)