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

Metastatic Colorectal Cancer Clinical Trial

— RegoSeq  

Official title:

Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06137170
• Other study ID #: 22581
• Status: Active, not recruiting
• Start date: March 1, 2024
• Est. completion date: November 29, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 29, 2024
• Est. primary completion date: November 29, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged =18 years at diagnosis of mCRC
• Histologically confirmed diagnosis of mCRC
• Received sequential treatment with regorafenib followed by TAS with or without Bevacizumab (R-TAS±BEV, without other therapies in-between) and vice versa (TAS±BEV -R without other therapies in-between) from January 1, 2013 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up
• Have at least 6 months of available data before index date (baseline period) and at least 3 months of follow-up data

Exclusion Criteria:

• Patients who had a diagnosis of any other primary cancer (including gastrointestinal stromal tumors (GIST) and hepatocellular carcinoma (HCC)) except non-melanoma skin cancers during baseline
• Patients involved in clinical trials during the study period

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
Follow clinical administration.

Locations

Country	Name	City	State
France	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of sequential treatment (DoT)		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Primary	Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatment		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Primary	Number and type of subsequent therapies		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Primary	Proportion of patients using myelopoiesis supporting therapy		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Primary	Overall Survival (OS)		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Descriptive analysis of demographic characteristics		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	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.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Location of primary cancer: left colon, right colon, rectum	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.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	TNM stage at diagnosis	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.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Metastasis location: lung, hepatic, other sites	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.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Molecular diagnostics status	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.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Regorafenib dose at starting treatment and changes during treatment	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.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Biomarkers: KRAS, NRAS & BRAF and MMR/MSI		Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary	Proportion of patients in the sequential treatment groups who received myelopoiesis supporting therapy, differentiating between prophylactic and for therapeutic purpose	Myelopoiesis supporting therapy including blood / blood cell transfusions, hematopoietic growth factors, e.g., granulocyte colony stimulating factor and erythropoiesis-stimulating agents.	Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up

External Links

•   Click here for access to information about Bayer's transparency standards and Bayer studies.