European Physician Survey of EGFR Inhibitor Prescribing Patterns

Metastatic Colorectal Cancer Clinical Trial

Official title:

Survey of Oncologists in Europe to Evaluate Their Knowledge of KRAS Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652833
• Other study ID #: 20101121
• Status: Completed
• Start date: March 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2022
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 453
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Trend survey of physicians performed over 3 years
Primary	Proportion of oncologists who conduct a KRAS test prior to the initiation of Vectibix treatment		Trend survey of physicians performed over 3 years
Primary	Proportion of oncologists who administer Vectibix in mCRC patients with mutant KRAS tumors or with KRAS status unknown		Trend survey of physicians performed over 3 years
Primary	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		Trend survey of physicians performed over 3 years

External Links

•   AmgenTrials clinical trials website