Investigating the Use of Regorafenib (Stivarga®) in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy

Colorectal Neoplasm Clinical Trial

— RECORA  

Official title:

RECORA- Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959269
• Other study ID #: 16665
• Secondary ID: SV1313
• Status: Completed
• Phase: N/A
• First received: October 8, 2013
• Last updated: March 7, 2018
• Start date: October 31, 2013
• Est. completion date: July 7, 2017

Study information

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

Clinical Trial Summary

The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: July 7, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:´

• Male or female patients = 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga.

• Patients must have signed an informed consent form

Exclusion Criteria:

Related Conditions & MeSH terms

• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Drug:
• Regorafenib (Stivarga, BAY 73-4506)
As determined by the treating physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		after 40 months
Secondary	Progression-free survival		after 40 months
Secondary	Time to progression		after 40 months
Secondary	Disease control rate (DCR)	Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease).	after 40 months
Secondary	Duration of Stivarga treatment	Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation)	after 40 months
Secondary	Tumor status at different visits	The tumor status at different visits will be evaluated according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable". The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories.	after 40 months
Secondary	Incidence of treatment emergent adverse events (TEAE)	Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug.	after 18 and 40 months

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