do_not_disturb_altRecruitment Complete
Metastatic colorectal cancer
Bayer Identifier:infoA unique number for a trial given by Bayer.
22581
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment
Trial purpose
This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied.
Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body.
The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying.
Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given.
To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries.
The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order.
To do this, researchers will collect the following information:
- how long participants received sequential treatment for mCRC
- number of participants receiving further treatment for mCRC after the sequential treatment
- number and type of further treatments for mCRC
- how long did participants live (also called overall survival).
The data will come from the participants’ information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants’ health for at least 3 months.
In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.
Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body.
The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying.
Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given.
To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries.
The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order.
To do this, researchers will collect the following information:
- how long participants received sequential treatment for mCRC
- number of participants receiving further treatment for mCRC after the sequential treatment
- number and type of further treatments for mCRC
- how long did participants live (also called overall survival).
The data will come from the participants’ information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants’ health for at least 3 months.
In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal info
200The overall number of participants needed for a trial.
Trial Dates info
March 2024 - March 2025Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
N/AA phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Stivarga (Regorafenib, BAY73-4506)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
| many locations | many locations, France | |
| many locations | many locations, Italy | |
| many locations | many locations, Spain |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Duration of sequential treatment (DoT)date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatmentdate_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Number and type of subsequent therapiesdate_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Proportion of patients using myelopoiesis supporting therapydate_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Overall Survival (OS)date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Descriptive analysis of demographic characteristicsdate_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- ECOG at index (the closest measurement before index date)Descriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Location of primary cancer: left colon, right colon, rectumDescriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- TNM stage at diagnosisDescriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Metastasis location: lung, hepatic, other sitesDescriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Molecular diagnostics statusDescriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Regorafenib dose at starting treatment and changes during treatmentDescriptive analysis of clinical characteristics: Descriptive statistics will be calculated. Categorical variables will be summarized using frequency (number of patients [N]) and percentage (%) of total study persons observed in each group. Continuous and count variables will be presented as the mean, standard deviation (SD) and median. As relevant, continuous variables will also be categorized into intervals.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Biomarkers: KRAS, NRAS & BRAF and MMR/MSIdate_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
- Proportion of patients in the sequential treatment groups who received myelopoiesis supporting therapy, differentiating between prophylactic and for therapeutic purposeMyelopoiesis supporting therapy including blood / blood cell transfusions, hematopoietic growth factors, e.g., granulocyte colony stimulating factor and erythropoiesis-stimulating agents.date_rangeTime Frame:Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Trial design
Trial Type info
ObservationalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
N/AThe main reason the clinical trial is being done.
Allocation info
N/AAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
N/AAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
N/AA “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.