Clinical trial NCT06137170: 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
Official title: Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective cohort study of patients aged ≥18 years at the diagnosis of mCRC in real world clinical practice who received sequential treatment with regorafenib followed by TAS (with or without Bevacizumab, R-TAS±BEV) and vice versa (TAS±BEV-R) from January 1, 2019 to December 31, 2022 (inclusion period), or the latest available date that allows at least 3 months of follow-up, at multiple clinical centers in France, Italy, and Spain. The study will use longitudinal patients and clinical data recorded at the centers.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of sequential treatment (DoT)
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Proportion of patients receiving subsequent therapies following sequential treatment during all available follow up after end of sequential treatment
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Number and type of subsequent therapies
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Proportion of patients using myelopoiesis supporting therapy
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Overall Survival (OS)
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Secondary outcomes:
measure: Descriptive analysis of demographic characteristics
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: ECOG at index (the closest measurement before index date)
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Location of primary cancer: left colon, right colon, rectum
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: TNM stage at diagnosis
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Metastasis location: lung, hepatic, other sites
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Molecular diagnostics status
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Regorafenib dose at starting treatment and changes during treatment
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Biomarkers: KRAS, NRAS & BRAF and MMR/MSI
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
measure: Proportion of patients in the sequential treatment groups who received myelopoiesis supporting therapy, differentiating between prophylactic and for therapeutic purpose
timeFrame: Retrospective analysis between January 1, 2013 and December 31, 2022 or the latest available date that allows at least 3 months follow-up
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
Study officials:
References: