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A Real World Study to Evaluate Effectiveness of Avastin (Bevacizumab) for First Line Treatment of Patients With Metastatic Colorectal Cancer and Known KRAS Status

A Non-Interventional Multi-country Study to Evaluate the Real World Effectiveness of Avastin (Bevacizumab) for First Line Treatment of Patients With Metastatic Colorectal Cancer and Known KRAS Status

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02831842
Enrollment
4278
Registered
2016-07-13
Start date
2016-06-09
Completion date
2017-11-30
Last updated
2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

This non-interventional study will meta-analyze overall survival outcomes among the participants with metastatic colorectal cancer (mCRC) with available V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) status, who received firstline treatment with bevacizumab containing treatment regimen in routine clinical practice. The study leveraging secondary data from existing cohorts in the United Stats of America (USA), Germany, Australia, and Denmark.

Interventions

DRUGAnti-EGFR-Containing Regimen

Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.

DRUGBevacizumab-containing regimen

Study protocol does not specify any particular bevacizumab containing regimen. The data will be collected retrospectively.

DRUGChemotherapy

Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants with metstatic colorectal cancer (mCRC) diagnosed at any point prior to March 2014 (United States \[US\] - Vector Oncology Protocol Sponsored by US Roche Pharma Medical Affairs), diagnosed between September 2006 and March 2015 (Germany - Tumourregister Kolorektales Karzinom \[TKK\] Registry Study Supported by German Roche Pharma Affiliate), diagnosed between September 2009 and December 2014 (Australia - Treatment of Recurrent and Advanced Colorectal Cancer \[TRACC\] Registry Supported by Roche Pharma Australia), diagnosed between 2009 and 2013 (Denmark - Roche Diagnostic Sponsored Study and Aarhus University Hospital, Department of Clinical Epidemiology) * Participants have been treated in first line with bevacizumab or Anti-EGFR treatment regimen or chemotherapy alone * Participants have to have available data on overall survival (OS), KRAS testing status, and left/right tumor location status

Exclusion criteria

N/A

Design outcomes

Primary

MeasureTime frame
Overall Survival (OS) in Participants With mCRC and a Documented KRAS Mutation who Received Bevacizumab-Containing Treatment or Chemotherapy Alone in Routine Clinical Practicestart of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)

Secondary

MeasureTime frame
OS in Participants With mCRC and a Documented KRAS Wild Type Status who Received Bevacizumab-Containing Treatment or Anti-EGFR Treatment in Routine Clinical Practicestart of first-line therapy to death from any cause, or to last date known that participant is alive (retrospective data collection over approximately 9 years)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026