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

Sponsor
Hoffmann-La Roche
Study ID
NCT02831842
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jul 13, 2016
Start date
Jun 9, 2016
Status verified
Jan 2018
Primary completion
Jun 9, 2016
Completion
Nov 30, 2017

Study Design

Enrollment
4,278 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

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) ]

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