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Completed

NCT Number: NCT02656524

Stivarga Real Life Evidence in Hungary

The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Budapest, Hungary

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).

Exclusion criteria

  • Not applicable

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

Product is used in accordance with SmPC

Primary outcomes

  1. Length of treatment for each treatment episode

    Time frame: Retrospective analysis of 2 year period

    The length of each treatment episode will be calculated based on the duration between the initiation date of a treatment episode and the end date of the same treatment episode

  2. Progression Free Survival (PFS)

    Time frame: Retrospective analysis of 2 year period

    PFS will be defined as days between start of the therapy and the date of the medical doctors opinion about progression (confirmed by radiology or clinical assessment)

  3. Overall Survival (OS)

    Time frame: Retrospective analysis of 2 year period

  4. Number of participants with treatment emergent adverse events as a measure of safety and tolerability

    Time frame: Retrospective analysis of 2 year period

Secondary outcomes

  1. Resource utilization per patient

    Time frame: Retrospective analysis of 2 year period

    Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing

Other outcomes

  1. Time to treatment failure (TTF)

    Time frame: Retrospective analysis of 2 year period

    Time to treatment failure is defined as days between the first drug delivery to the health care provider and date of treatment discontinuation due to any reason, including death

  2. Time to progression (TTP)

    Time frame: Retrospective analysis of 2 year period

    Time to progression is defined as days between the first drug delivery to the health care provider and the date of progression defined by the medical doctor

  3. Characteristics of patients with better response

    Time frame: Retropsective analysis of 2 year period

    Patients with "better response" are defined as receiving more cycles of regorafenib treatment than the median number of cycles (2 cycles). Their distribution is analyzed by KRAS status, by the location of the primary tumour, by age, by prior cancer therapies and by location of metastases.

  4. Time frame between the baseline computed tomography and the first drug delivery

    Time frame: Retrospective analysis of 2 year period

    Time frame between the date of the baseline computed tomography (CT) and the date of the first drug delivery to the health care provider

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Effectiveness of Stivarga (Regorafenib) for Patients With Metastatic Colorectal Cancer in the Hungarian Real World Setting

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2016
Registry last updated
Feb 12, 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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