Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib (COLONG)

May 14, 2018 updated by: Bayer

COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Multiple Locations, Belgium
        • Belgium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.

Description

Inclusion Criteria:

  • Male or female patients ≥ 18 years of age.
  • Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July 2017.
  • Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment.
  • Sufficient kidney, liver and bone marrow function start of Stivarga treatment.
  • Life expectancy ≥ 3 months at start of Stivarga treatment

Exclusion Criteria:

- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Regorafenib_DoT<4 months
DoT < 4 months
Drug: Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)
Regorafenib_4 months ≤ DoT < 12 months
4 months ≤ DoT < 12 months
Drug: Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)
Regorafenib_DoT ≥ 12 months
DoT ≥ 12 months
Drug: Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG performance status (0, 1)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG: Eastern Cooperative Oncology Group
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary site of disease
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Tumor resection (yes, no, unknown)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Specific site of metastasis
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
KRAS mutation (yes, no, unknown)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
RAS mutation (yes, no, unknown)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
BRAF mutation (yes, no, unknown)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Start date of Stivarga treatment
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Reason for discontinuation of Stivarga treatment
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
progression - symptomatic, Progression - radiological, Progression - radiological + symptomatic, Progression - unknown, Intolerability, Death, other, unknown, not applicable
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Subsequent mCRC treatment
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Chemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicable
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Last daily Stivarga dose
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
80 mg, 120 mg, 160 mg, other, unknown
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Duration of treatment (months)
Time Frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19577 (Other Identifier: HiREB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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