Overview

This trial is active, not recruiting.

Condition colorectal cancer
Sponsor Hoffmann-La Roche
Start date December 2012
End date March 2018
Trial size 2947 participants
Trial identifier NCT01775644, ML28120

Summary

This observastonal multicenter study will evaluate the differences of progression-free survival in defined subgroups of patients with metastatic colorectal cancer receiving Avastin (bevacizumab). Further, safety and efficacy in daily routine will be assessed. Data will be collected for up to 5 years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Differences in progression-free survival of patient subgroups
time frame: 5 years

Secondary Outcomes

Measure
Clinical/demographic patient characteristics at initiation of treatment
time frame: 5 years
Progression-free survival in daily routine
time frame: 5 years
Overall response in daily routine
time frame: 5 years
Response rate in daily routine
time frame: 5 years
Treatment schemes in daily routine
time frame: 5 years
Safety: incidence of adverse events
time frame: 5 years
Reason for treatment modifications/discontinuation
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age >= 18 years - Patients with metastatic colorectal cancer where investigators have decided to give a first-line, fluoro-pyrimidine-based combination therapy with Avastin® according to Summary of Product Characteristics (SmPC) - Written and signed informed consent prior to onset of documentation Exclusion Criteria: - Contraindications for Avastin® according to Summary of Products Characteristics (SmPC)

Additional Information

Official title Non-interventional Study of Avastin® First-line in Metastatic Colorectal Cancer (Koralle)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.