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

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Anti-EGFR-Containing Regimen; Drug: Bevacizumab-containing regimen; Drug: Chemotherapy

• Registration Number: NCT02831842
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2016-06-09
• Primary Completion: 2016-06-09
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-12
• Study First Posted: 2016-07-13
• Study Completion: 2017-11-30
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4278

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

Read More

Exclusion Criteria

N/A

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mCRC Participants	Anti-EGFR-Containing Regimen	Data of mCRC participants who received first-line treatment with bevacizumab-containing regimen or with chemotherapy alone and had KRAS-mutant status and mCRC participants who received first-line treatment with bevacizumab-containing regimen or an anti-epidermal growth factor receptor (EGFR)-containing regimen and had KRAS wild type status, will be collected retrospectively.
mCRC Participants	Chemotherapy	Data of mCRC participants who received first-line treatment with bevacizumab-containing regimen or with chemotherapy alone and had KRAS-mutant status and mCRC participants who received first-line treatment with bevacizumab-containing regimen or an anti-epidermal growth factor receptor (EGFR)-containing regimen and had KRAS wild type status, will be collected retrospectively.
mCRC Participants	Bevacizumab-containing regimen	Data of mCRC participants who received first-line treatment with bevacizumab-containing regimen or with chemotherapy alone and had KRAS-mutant status and mCRC participants who received first-line treatment with bevacizumab-containing regimen or an anti-epidermal growth factor receptor (EGFR)-containing regimen and had KRAS wild type status, will be collected retrospectively.

Primary Outcome Measures

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

Name	Time	Method
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	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)