Clinical trial NCT02042144: Safety and Effectiveness of Regorafenib
Official title: Correlate - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Keywords: Neoplasms, Colorectal
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 1034
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3
timeFrame: Up to 42 months
Secondary outcomes:
measure: Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.
timeFrame: Up to 42 months
measure: 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.
timeFrame: Up to 42 months
measure: 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.
timeFrame: Up to 42 months
measure: Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries
timeFrame: Up to 42 months
measure: Healthcare resource utilization
timeFrame: Up to 42 months
Other outcomes:
Locations:
city: Multiple Locations
country: Argentina
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: France
city: Multiple Locations
country: Italy
city: Multiple Locations
country: Luxembourg
city: Multiple Locations
country: Mexico
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Singapore
city: Multiple Locations
country: Spain
city: Multiple Locations
country: Switzerland
city: Multiple Locations
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.