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OpenTrials
Completed

NCT Number: NCT02042144

Safety and Effectiveness of Regorafenib

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.

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Key information

Conditions

Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Up to 42 months

Secondary outcomes

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

    Time frame: Up to 42 months

  2. 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.

    Time frame: Up to 42 months

  3. 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.

    Time frame: Up to 42 months

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

    Time frame: Up to 42 months

  5. Healthcare resource utilization

    Time frame: Up to 42 months

    Hospitalization (Date, Length), Concomitant medication and procedures and any other anticancer therapies

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Correlate - Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings

Acronym: Correlate

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 22, 2014
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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