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European Physician Survey of EGFR Inhibitor Prescribing Patterns

Completed
Conditions
Metastatic Colorectal Cancer
Interventions
Other: Physician Survey
Registration Number
NCT01652833
Lead Sponsor
Amgen
Brief Summary

To ensure the appropriate administration of Vectibix for the treatment of mCRC with wild-type KRAS in real-world practice, it is important to understand the awareness of practicing oncologists regarding the correct indication and appropriate administration of Vectibix. It is also critical to monitor changes in oncologists' awareness and practice between the different rounds of the study.

Detailed Description

The survey will be conducted for 3 rounds in months 0, 12, and 24 after the first interview.

Before the beginning of each round, a sampling list will be created by Amgen.

In each round of the survey, potential participating oncologists will be sampled from each country's sampling list through random sampling and reached through telephone, letter or email. During the initial contact, the oncologists will be assessed for their eligibility to participate in the study by using a standardized screening questionnaire.

The initial contact and screening of potential participating oncologists will continue until a total of 150 eligible oncologists agree to participate in each round. The number of oncologists sampled in each country will be proportional to the use of Vectibix in each country and the number of oncology physicians estimated to prescribe Vectibix. Each eligible oncologist can only participate in 1 of the 3 rounds of survey.

Study staff will then conduct the survey with each of the identified eligible oncologists over the telephone, using a standardized questionnaire. Information about their awareness of the correct indication and appropriate administration of Vectibix and their experience in the administration of Vectibix treatment in the previous 6 months will be collected. We will make every attempt to collect the correct information from participating oncologists. This may require at least two phone calls to allow an oncologist to review their notes in order to report the correct data.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
453
Inclusion Criteria
  • Must be a practicing oncology specialist
  • Must treat at least 3 new or continuing patients with metastatic colorectal cancer in the last quarter
  • Must have prescribed Vectibix within the last 6 months to metastatic colorectal cancer patients
Exclusion Criteria
  • Must not have taken part in this study previously
  • Must not have participated in Amgen study number 20101120.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Round 2Physician Surveysurvey of 150 oncologists approximately 12 months after round 1
Round 3Physician Surveysurvey of 150 oncologists approximately 24 months after round 1
Round 1Physician Surveysurvey of 150 oncologists
Primary Outcome Measures
NameTimeMethod
Proportion of oncologists who are aware of the correct indication of Vectibix, with regard to tumor KRAS status and who conduct a KRAS test prior to initiation of Vectibix treatmentTrend survey of physicians performed over 3 years
Proportion of oncologists who conduct a KRAS test prior to the initiation of Vectibix treatmentTrend survey of physicians performed over 3 years
Proportion of oncologists who administer Vectibix in mCRC patients with mutant KRAS tumors or with KRAS status unknownTrend survey of physicians performed over 3 years
Proportion of oncologists who administer Vectibix simultaneously with oxaliplatin-containing chemotherapy in mCRC patients with mutant KRAS tumors or patients with tumor KRAS status unknownTrend survey of physicians performed over 3 years
Secondary Outcome Measures
NameTimeMethod
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