Metastatic Colorectal CancerRE-SEARCHNCT04920422
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.
An observational study of Metastatic Colorectal Cancer, run by Bayer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 242 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2021to 7 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spanish participants will be included in this study if they had at least one dose of regorafenib in past treatment cycle.
Who may be able to join
- 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
Who cannot join
- Patient who have been treated with regorafenib during their participation in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosing Patterns With Regorafenib in Clinical Practice in Spain: A Retrospective Study.
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.
Read more
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
- Being tested
- No intervention
- Keywords
- Colorectal cancer, Refractory metastatic colorectal cancer, Observational Study, Regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Retrospective analysis using database without any intervention assigned in the study.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic colorectal cancer patients. | Medical history data of all patients with at least 1 treatment with regorafenib will be collected retrospectively. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that start regorafenib treatment with a dose of 80 mg.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
At index (at regorafenib start date)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start15 Jul 2021
- Primary completion7 Oct 2022
- Study completion7 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920422
- Sponsor's protocol ID
- 21749
- Acronym
- RE-SEARCH
- Status last verified
- Oct 2023
- First submitted
- 3 Jun 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing Patterns With Regorafenib in Clinical Practice in Spain: A Retrospective Study.
- ClinicalTrials.gov ID
- NCT04920422
- Acronym / sponsor ID
- RE-SEARCH / 21749
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal cancer, Refractory metastatic colorectal cancer, Observational Study, Regorafenib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Oct 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic colorectal cancer patients. | – | Other: No interventionMedical history data of all patients with at least 1 treatment with regorafenib will be collected retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spanish participants will be included in this study if they had at least one dose of regorafenib in past treatment cycle.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient who have been treated with regorafenib during their participation in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionRetrospective analysis using database without any intervention assigned in the study. | Other | Metastatic colorectal cancer patients. |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Median progression free survival
Time frame: 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.
Time frame: 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.
Time frame: Retrospective data analysis from January 2017 to at least 3 months prior to being included in the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Bayer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.