An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions

Metastatic Colorectal Cancer (mCRC) Clinical Trial

— STAR-T  

Official title:

(STAR-T) Sequential TreAtment With Regorafenib and Trifluridine/Tipiracil (TAS-102, With or Without Bevacizumab) in Refractory Metastatic Colorectal Cancer: Real-world Outcomes in Community Clinical Practice in the USA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05839951
• Other study ID #: 22386
• Status: Active, not recruiting
• Start date: April 24, 2023
• Est. completion date: October 31, 2024

Study information

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

Clinical Trial Summary

This is an observational study using data that has been collected from participants who received their usual treatments.

Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus) that has spread to other parts of the body.

Regorafenib is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. The combination of anti-cancer drugs trifluridine and tipiracil is called TAS-102. It prevents cancer cells from growing and multiplying.

Both regorafenib and TAS-102 are approved treatments for metastatic colorectal cancer and are available for doctors to prescribe to people with mCRC after previous lines of treatment have been unsuccessful.

Regorafenib and TAS-102 work in different ways and impact people differently. People might receive one of these drugs first and followed by the other. The best sequence for taking these drugs is still unclear.

Researchers have also found that TAS-102, when taken with another anti-cancer drug called bevacizumab, helps people live longer than when taken alone.

To better understand the impact of the sequence of taking regorafenib and TAS-102 (with or without bevacizumab), more knowledge is needed about how these work together in people with mCRC in real world settings.

The main purpose of this study is to learn more about the characteristics and impact of treatment in people with mCRC who received regorafenib and TAS-102 (with or without bevacizumab) one after the other. This information will be grouped based on their treatment sequence and age group (less or more than 65 years old).

In addition, the researchers want to learn about :

• how long participants were treated with regorafenib and TAS-102 taken one after the other in a sequential order,

• any treatment for mCRC that the participants received after the sequential treatment,

• any treatment received for a condition in which the bone marrow cannot make up enough blood cells (a common side effect of cancer treatment), during the sequential treatment,

• if and how often white blood cells that fight infection decreased during the sequential treatment,

• the number of hospital or testing facility visits that participants had during the sequential treatment, and

• how long did participants live (also called overall survival).

The participants in this study had already received regorafenib and TS-102 (with or without bevacizumab) as part of their regular care from their doctors.

The data will come from the participants' information stored in an electronic health records database called Flatiron mCRC EDM. Data collected will be from January 2015 to December 2022.

Researchers will only look at the health information from adults in the United States of America.

In this study, only available data from routine care is collected. No visits or tests will be required as part of this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 818
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who had diagnosis of mCRC (=18 years old at diagnosis of mCRC)

• Received sequential treatment of regorafenib and TAS-102 (either mono or with bevacizumab) after mCRC diagnosis, with at least one documented clinical visit on or after treatment; OR

• Patients with mCRC who received combo use of TAS+BEV, with at least one documented clinical visit on or after treatment

Exclusion Criteria:

• Patients who had a diagnosis of gastrointestinal stromal tumors (GIST) or hepatocellular carcinoma (HCC) or other primary cancers in the baseline period (i.e., 6 months prior to index date) except non-melanoma skin cancers

• Patients involved in clinical trials during the study period (as indicated by the masked therapies)

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer (mCRC)

Intervention

Drug:
• Regorafenib (BAY73-4506, Stivarga®)
Oral multitargeted kinase inhibitor
• TAS-102 (trifluridine and tipiracil, Lonsurf®)
Oral cytotoxic chemotherapy
• Bevacizumab
VEGFR inhibitor

Locations

Country	Name	City	State
United States	Many locations	Whippany	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort R-T or Cohort T-R: Descriptive analysis of demographic	Demographic includes age, gender, race and ethnicity, insurance.	Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Primary	Cohort R-T or Cohort T-R: Descriptive analysis of clinical characteristics	Clinical characteristics includes number and type of prior therapies patient received for mCRC, stage at initial diagnosis, performance status, histology, time since metastatic diagnosis, Line of Treatment (LOT) of index treatment	Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Primary	Cohort R-T or Cohort T-R: Descriptive analysis of biomarker Kirsten rat sarcoma 2 viral oncogene homolog (KRAS)	Biomarker B-Raf Proto-Oncogene (BRAF) and Mismatch Repair / Microsatellite instability (MMR/MSI) will be explored depending on data availability.	Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Duration of sequential treatment		Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Proportion of patients receiving subsequent therapies		Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Type of subsequent therapies		Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Frequency of myelosuppression related medical interventions during sequential treatment	Myelosuppression related medical interventions [e.g., use of Granulocyte colony stimulating factors (G-CSF)]	Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Frequency and incidence rate of neutropenia during sequential treatment		Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Number of patients with health care resource utilizations during sequential treatment	Health care resource utilizations includes office/hospital visit and lab visit.	Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary	Cohort R-T or Cohort T-R: Overall survival of patients with Regorafenib followed by TAS-102 and vice versa in 3rd line treatment and 4th line treatment		Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)

External Links

•   Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.