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Completed

NCT Number: NCT04920422

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.

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. Percentage of patients that start regorafenib treatment with a dose of 80 mg.

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

  2. Percentage of patients that start regorafenib treatment with a dose of 120 mg

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

  3. Percentage of patients that start regorafenib treatment with a dose of 160 mg

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

  4. Percentage of patients that follow each dosing patterns during first two cycles of treatment

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

Secondary outcomes

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

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

    At index (at regorafenib start date)

  2. Percentage of patients according to number of previous lines received at index.

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

    At index (at regorafenib start date)

  3. Median time from mCRC diagnosis

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

    At index (at regorafenib start date)

  4. Median number of metastatic locations

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

    At index (at regorafenib start date)

  5. Percentage of patients with ECOG performance status at index

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

    ECOG: Eastern Cooperative Oncology Group.

  6. Percentage of patients with comorbidities at index.

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

    At index (at regorafenib start date)

  7. Percentage of patients with mutated BRAF status at index

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

    At index (at regorafenib start date)

  8. Percentage of patients with mutated KRAS status at index.

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

    At index (at regorafenib start date)

  9. Median duration of regorafenib treatment (cycles)

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

    At follow-up

  10. Median progression free survival

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

    At follow-up

  11. Percentage of patients for each reason of dose modification.

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

    At follow-up

  12. Percentage of patients that start cycle 3 based on dosing patterns.

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: RE-SEARCH

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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