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

Colorectal Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831842
• Other study ID #: MO30177
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: January 24, 2018
• Start date: June 9, 2016
• Est. completion date: November 30, 2017

Study information

• Verified date: January 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4278
• Est. completion date: November 30, 2017
• Est. primary completion date: June 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Anti-EGFR-Containing Regimen
Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.
• Bevacizumab-containing regimen
Study protocol does not specify any particular bevacizumab containing regimen. The data will be collected retrospectively.
• Chemotherapy
Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)