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
  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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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: April 2015
Estimated Primary Completion Date: April 2015 (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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652833

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  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 1, 2014
Health Authority: France: French Data Protection Authority
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Spain: Spanish Agency of Medicines
Italy: Italian Medicines Agency
Netherlands: Medical Ethical Review Committee South West Holland
Sweden: Regional Ethics Review Board Gothenburg
Denmark: Sundhedsstyrelsen
Belgium: 2 ECs contacted for information only

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 October 02, 2014