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

NCT02831842 | Completed

• 1 other identifier: MO30177
• Study Type: observational
• Target: 4,278
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (1)

mCRC Participants

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.

Drug: Anti-EGFR-Containing Regimen; Drug: Bevacizumab-containing regimen; Drug: Chemotherapy

Interventions

Anti-EGFR-Containing Regimen DRUG

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

mCRC Participants

Bevacizumab-containing regimen DRUG

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

Also known as: Avastin

mCRC Participants

Chemotherapy DRUG

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

mCRC Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with mCRC and known KRAS status who received bevacizumab as first-line treatment.

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Drug Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Germany: PEI Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 13, 2016
• Study Start: June 9, 2016
• Primary Completion: June 9, 2016
• Study Completion: November 30, 2017
• Last Updated: January 26, 2018

Record last verified: 2018-01