European Physician Survey of EGFR Inhibitor Prescribing Patterns
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metastatic Colorectal Cancer |
Other: Physician Survey |
| Study Type: | Observational |
| Study Design: | Time Perspective: Cross-Sectional |
| Official Title: | Survey of Oncologists in Europe to Evaluate Their Knowledge of KRAS Testing |
- 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 ]
| Estimated Enrollment: | 450 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Round 1
survey of 150 oncologists
|
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 2
survey of 150 oncologists approximately 12 months after round 1
|
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 3
survey of 150 oncologists approximately 24 months after round 1
|
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
|
Detailed Description:
The survey will be conducted for 3 rounds in months 0, 12, and 24 after the first interview.
Before the beginning of the study, a sampling list will be created by merging lists of oncologists (and their contact information) to be collected from Cegedim, the European Society of Medical Oncology (ESMO), and from major cancer centers and oncology clinics in 5 countries of Europe, including France, Germany, Italy, Spain and the Czech Republic.
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 recruited in each country will be proportional to the use of Vectibix. The minimum and maximum for the number of oncologists in each country for each round of survey are proposed to be: 35-50 for France and Germany; 15-35 for Italy and Spain and 10-15 for Czech Republic. We will attempt to sample the numbers of oncologists in each country according to these ranges. Each eligible oncologist can only answer the survey questions 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Physician's satisfying all of the eligibility criteria are eligible to be enrolled in the survey
Physician Inclusion Criteria:
- Must be a practicing oncology specialist
- Must treat at least 5 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01652833 History of Changes |
| Other Study ID Numbers: | 20101121 |
| Study First Received: | June 5, 2012 |
| Last Updated: | July 26, 2012 |
| Health Authority: | France: French Data Protection Authority Germany: Paul-Ehrlich-Institut Czech Republic: State Institute for Drug Control Spain: Spanish Agency of Medicines |
Keywords provided by Amgen:
|
Metastatic Colorectal Cancer |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013