Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT03386825
• Lead Sponsor: Bayer

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2017-12-29
• Study Start: 2018-01-31
• Status Verified: 2018-05
• Primary Completion: 2018-05-01
• Study Completion: 2018-05-01
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Regorafenib_4 months ≤ DoT < 12 months	Regorafenib (Stivarga, BAY73-4506)	4 months ≤ DoT \< 12 months
Regorafenib_DoT ≥ 12 months	Regorafenib (Stivarga, BAY73-4506)	DoT ≥ 12 months
Regorafenib_DoT<4 months	Regorafenib (Stivarga, BAY73-4506)	DoT \< 4 months

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG performance status (0, 1)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017	ECOG: Eastern Cooperative Oncology Group
Primary site of disease	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)
Tumor resection (yes, no, unknown)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Specific site of metastasis	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017	Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown
KRAS mutation (yes, no, unknown)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
RAS mutation (yes, no, unknown)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
BRAF mutation (yes, no, unknown)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Secondary Outcome Measures

Name	Time	Method
Start date of Stivarga treatment	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)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Reason for discontinuation of Stivarga treatment	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
Subsequent mCRC treatment	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
Last daily Stivarga dose	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017	80 mg, 120 mg, 160 mg, other, unknown
Duration of treatment (months)	Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Trial Locations

Locations (1)

Belgium; 🇧🇪 Multiple Locations, Belgium