NCT02042144

Brief Summary

This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,034

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
13 countries

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 8, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2017

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

3.4 years

First QC Date

January 20, 2014

Last Update Submit

January 12, 2018

Conditions

Neoplasms

Keywords

Neoplasms, Colorectal

Outcome Measures

Primary Outcomes (1)

  • Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3

    Up to 42 months

Secondary Outcomes (5)

  • Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.

    Up to 42 months

  • Progression free survival (PFS) is defined as the time interval measured from the day of start with regorafenib treatment to (radiological or clinical) progression or death, whichever comes first.

    Up to 42 months

  • Disease control rate (DCR) - DCR is defined as percentage of patients, whose best response was not progressive disease (i.e. CR, PR or SD). Stable disease must be at least 6 weeks in duration.

    Up to 42 months

  • Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries

    Up to 42 months

  • Healthcare resource utilization

    Up to 42 months

Study Arms (1)

Group 1

Drug: Stivarga (Regorafenib, BAY73-4506)

Interventions

Stivarga (Regorafenib, BAY73-4506)DRUG

Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib.

You may qualify if:

  • Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib.

You may not qualify if:

  • Patients participating in an investigational program with interventions outside of routine clinical practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Unknown Facility

Multiple Locations, Argentina

Location

Unknown Facility

Multiple Locations, Austria

Location

Unknown Facility

Multiple Locations, Czechia

Location

Unknown Facility

Multiple Locations, Denmark

Location

Unknown Facility

Multiple Locations, France

Location

Unknown Facility

Multiple Locations, Italy

Location

Unknown Facility

Multiple Locations, Luxembourg

Location

Unknown Facility

Multiple Locations, Mexico

Location

Unknown Facility

Multiple Locations, Netherlands

Location

Unknown Facility

Multiple Locations, Singapore

Location

Unknown Facility

Multiple Locations, Spain

Location

Unknown Facility

Multiple Locations, Switzerland

Location

Unknown Facility

Multiple Locations, Taiwan

Location

Related Publications (3)

  • Cervantes A, Tabernero J, Garcia-Carbonero R, Sastre J, Feliu J, Carmen Guillen-Ponce, Paredes BG, Carral A, Munoz J. Regorafenib in patients with metastatic colorectal cancer in Spain: from clinical trials to real-world evidence. Future Oncol. 2024;20(20):1401-1413. doi: 10.1080/14796694.2024.2340422. Epub 2024 Jun 11.

    PMID: 38861286DERIVED

  • Yeh KH, Yang TS, Hsu TC, Tzu-Liang Chen W, Chen HH, Teng HW, Lin BW, Kuan FC, Chiang FF, Duann CW, Li YS, Lin MT, Fiala-Buskies S, Ducreux M, Wang JY. Real-world evidence of the safety and effectiveness of regorafenib in Taiwanese patients with metastatic colorectal cancer: CORRELATE Taiwan. J Formos Med Assoc. 2021 Nov;120(11):2023-2031. doi: 10.1016/j.jfma.2020.12.015. Epub 2021 Jan 7.

    PMID: 33422398DERIVED

  • Ducreux M, Petersen LN, Ohler L, Bergamo F, Metges JP, de Groot JW, Wang JY, Garcia Paredes B, Dochy E, Fiala-Buskies S, Cervantes A, O'Connor JM, Falcone A; CORRELATE Investigators. Safety and effectiveness of regorafenib in patients with metastatic colorectal cancer in routine clinical practice in the prospective, observational CORRELATE study. Eur J Cancer. 2019 Dec;123:146-154. doi: 10.1016/j.ejca.2019.09.015. Epub 2019 Nov 4.

    PMID: 31698328DERIVED

MeSH Terms

Conditions

NeoplasmsColorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

January 22, 2014

Study Start

April 8, 2014

Primary Completion

August 19, 2017

Study Completion

November 10, 2017

Last Updated

January 16, 2018

Record last verified: 2018-01

Locations

AR(1)SG(1)ES(1)CH(1)DK(1)AU(1)IT(1)TW(1)FR(1)ME(1)NL(1)CZ(1)LU(1)