Clinical trial NCT05839951: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: Colon rectal cancer
Chemotherapy
Targeted medicine
Regorafenib
TAS-102
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 818
Sex: ALL
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: Patients with mCRC who received sequential treatment of Regorafenib and TAS-102 (with or without Bev), and patients with mCRC who received combo use of TAS+BEV from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cut) from Flatiron CRC EDM data (v Dec 2022 or the latest version)

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cohort R-T or Cohort T-R: Descriptive analysis of demographic
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Descriptive analysis of clinical characteristics
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Descriptive analysis of biomarker Kirsten rat sarcoma 2 viral oncogene homolog (KRAS)
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Secondary outcomes:
measure: Cohort R-T or Cohort T-R: Duration of sequential treatment
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Proportion of patients receiving subsequent therapies
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Type of subsequent therapies
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Frequency of myelosuppression related medical interventions during sequential treatment
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Frequency and incidence rate of neutropenia during sequential treatment
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: Cohort R-T or Cohort T-R: Number of patients with health care resource utilizations during sequential treatment
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
measure: 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
timeFrame: Retrospective analysis period is from Jan 2015 to Sep 2022 (or 3 months prior to the latest data cutoff date)
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Many locations
state: New Jersey
Study officials:
References: