Stivarga Real Life Evidence in Hungary

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656524
• Other study ID #: 18686
• Status: Completed
• Phase: N/A
• First received: December 21, 2015
• Last updated: February 9, 2018
• Start date: July 1, 2016
• Est. completion date: February 15, 2017

Study information

• Verified date: February 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY73-4506)
Product is used in accordance with SmPC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to treatment failure (TTF)	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	Retrospective analysis of 2 year period
Other	Time to progression (TTP)	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	Retrospective analysis of 2 year period
Other	Characteristics of patients with better response	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.	Retropsective analysis of 2 year period
Other	Time frame between the baseline computed tomography and the first drug delivery	Time frame between the date of the baseline computed tomography (CT) and the date of the first drug delivery to the health care provider	Retrospective analysis of 2 year period
Primary	Length of treatment for each treatment episode	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	Retrospective analysis of 2 year period
Primary	Progression Free Survival (PFS)	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)	Retrospective analysis of 2 year period
Primary	Overall Survival (OS)		Retrospective analysis of 2 year period
Primary	Number of participants with treatment emergent adverse events as a measure of safety and tolerability		Retrospective analysis of 2 year period
Secondary	Resource utilization per patient	Costs per patient for the reimbursed healthcare service e.g. inpatient care, outpatient visit, emergency departement visit, pharmaceutical dispensing	Retrospective analysis of 2 year period

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