Overview

This trial is active, not recruiting.

Condition colorectal neoplasm
Treatment regorafenib (stivarga, bay 73-4506)
Sponsor Bayer
Start date October 2013
End date March 2017
Trial size 483 participants
Trial identifier NCT01959269, 16665, SV1313

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients treated with Stivarga as 3rd or 4th line treatment, no intervention
regorafenib (stivarga, bay 73-4506)
As determined by the treating physician

Primary Outcomes

Measure
Overall survival
time frame: after 40 months

Secondary Outcomes

Measure
Progression-free survival
time frame: after 40 months
Time to progression
time frame: after 40 months
Disease control rate (DCR)
time frame: after 40 months
Duration of Stivarga treatment
time frame: after 40 months
Tumor status at different visits
time frame: after 40 months
Incidence of treatment emergent adverse events (TEAE)
time frame: after 18 and 40 months

Eligibility Criteria

Male or female participants at least 18 years old.

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:

Additional Information

Official title RECORA- Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) After Failure of Standard Therapy.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.