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European Physician Survey of EGFR Inhibitor Prescribing Patterns

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01652833
First received: June 5, 2012
Last updated: July 1, 2014
Last verified: July 2014

June 5, 2012
July 1, 2014
March 2012
April 2015   (final data collection date for primary outcome measure)
  • 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 treatment [ Time Frame: Trend survey of physicians performed over 3 years ] [ Designated as safety issue: No ]
  • Proportion of oncologists who conduct a KRAS test prior to the initiation of Vectibix treatment [ Time Frame: Trend survey of physicians performed over 3 years ] [ Designated as safety issue: No ]
  • Proportion of oncologists who administer Vectibix in mCRC patients with mutant KRAS tumors or with KRAS status unknown [ Time Frame: Trend survey of physicians performed over 3 years ] [ Designated as safety issue: No ]
  • Proportion of oncologists who administer Vectibix simultaneously with oxaliplatin-containing chemotherapy in mCRC patients with mutant KRAS tumors or patients with tumor KRAS status unknown [ Time Frame: Trend survey of physicians performed over 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01652833 on ClinicalTrials.gov Archive Site
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European Physician Survey of EGFR Inhibitor Prescribing Patterns
Survey of Oncologists in Europe to Evaluate Their Knowledge of KRAS Testing

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.

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.

Observational
Time Perspective: Cross-Sectional
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Probability Sample

Physician's satisfying all of the eligibility criteria are eligible to be enrolled in the survey

Metastatic Colorectal Cancer
Other: Physician Survey
Eligible physicians will be contacted via telephone to perform the physician survey. A standardised questionnaire will be used to collect information about the physician's awareness of the correct indication and appropriate administration of Vectibix and the physician's experience in the administration of Vectibix treatment in the previous 6 months
  • Round 1
    survey of 150 oncologists
    Intervention: Other: Physician Survey
  • Round 2
    survey of 150 oncologists approximately 12 months after round 1
    Intervention: Other: Physician Survey
  • Round 3
    survey of 150 oncologists approximately 24 months after round 1
    Intervention: Other: Physician Survey
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
450
April 2015
April 2015   (final data collection date for primary outcome measure)

Physician 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01652833
20101121
No
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP