Metastatic Colorectal CancerNCT01652833
European Physician Survey of EGFR Inhibitor Prescribing Patterns
An observational study of Metastatic Colorectal Cancer, run by Amgen.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Physician Survey
- How many people
- 453 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physician's satisfying all of the eligibility criteria are eligible to be enrolled in the survey
Who may be able to join
None listed.
Who cannot join
- Must not have taken part in this study previously
- Must not have participated in Amgen study number 20101120.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Physician Survey
- Keywords
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician SurveyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Round 1 | survey of 150 oncologists Receives: Other: Physician Survey | |
| Round 2 | survey of 150 oncologists approximately 12 months after round 1 Receives: Other: Physician Survey | |
| Round 3 | survey of 150 oncologists approximately 24 months after round 1 Receives: Other: Physician Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Trend survey of physicians performed over 3 years
Proportion of oncologists who conduct a KRAS test prior to the initiation of Vectibix treatment
Measured: Trend survey of physicians performed over 3 years
Proportion of oncologists who administer Vectibix in mCRC patients with mutant KRAS tumors or with KRAS status unknown
Measured: Trend 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 unknown
Measured: Trend survey of physicians performed over 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 453 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652833
- Sponsor's protocol ID
- 20101121
- Status last verified
- Sep 2022
- First submitted
- 5 Jun 2012
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey of Oncologists in Europe to Evaluate Their Knowledge of KRAS Testing
- ClinicalTrials.gov ID
- NCT01652833
- Acronym / sponsor ID
- 20101121
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Round 1 | – | Other: Physician Surveysurvey of 150 oncologists |
| Round 2 | – | Other: Physician Surveysurvey of 150 oncologists approximately 12 months after round 1 |
| Round 3 | – | Other: Physician Surveysurvey of 150 oncologists approximately 24 months after round 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physician's satisfying all of the eligibility criteria are eligible to be enrolled in the survey
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Must not have taken part in this study previously
- Must not have participated in Amgen study number 20101120.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician SurveyEligible 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 | Other | Round 1, Round 2, Round 3 |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.