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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02831842
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Colorectal Cancer Drug: Anti-EGFR-Containing Regimen Drug: Bevacizumab-containing regimen Drug: Chemotherapy

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Study Type : Observational
Actual Enrollment : 4278 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 9, 2016
Actual Primary Completion Date : June 9, 2016
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Group/Cohort Intervention/treatment
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
Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.

Drug: Bevacizumab-containing regimen
Study protocol does not specify any particular bevacizumab containing regimen. The data will be collected retrospectively.
Other Name: Avastin

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




Primary Outcome Measures :
  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 [ 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 Outcome Measures :
  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 [ 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with mCRC and known KRAS status who received bevacizumab as first-line treatment.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831842


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Germany: PEI Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02831842    
Other Study ID Numbers: MO30177
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors