Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

NCT ID: NCT03386825

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Regorafenib_DoT<4 months

DoT \< 4 months

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Antineoplastic agents, protein kinase inhibitor (L01XE21)

Regorafenib_4 months ≤ DoT < 12 months

4 months ≤ DoT \< 12 months

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Antineoplastic agents, protein kinase inhibitor (L01XE21)

Regorafenib_DoT ≥ 12 months

DoT ≥ 12 months

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Antineoplastic agents, protein kinase inhibitor (L01XE21)

Interventions

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Regorafenib (Stivarga, BAY73-4506)

Antineoplastic agents, protein kinase inhibitor (L01XE21)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Belgium

Multiple Locations, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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19577

Identifier Type: -

Identifier Source: org_study_id

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