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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anti-EGFR-Containing Regimen

Drug

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

Bevacizumab-containing regimen

Drug

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

Other names: Avastin

Chemotherapy

Drug

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

Primary outcomes

Overall Survival (OS) in Participants With mCRC and a Documented KRAS Mutation who Received Bevacizumab-Containing Treatment or Chemotherapy Alone in Routine Clinical Practice

Time frame: start 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 outcomes

OS in Participants With mCRC and a Documented KRAS Wild Type Status who Received Bevacizumab-Containing Treatment or Anti-EGFR Treatment in Routine Clinical Practice

Time frame: start 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Jul 13, 2016
Registry last updated: Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed