NCT01652833

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
453

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

2.7 years

First QC Date

June 5, 2012

Last Update Submit

September 8, 2022

Conditions

Keywords

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

  • 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

  • Proportion of oncologists who conduct a KRAS test prior to the initiation of Vectibix treatment

    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

    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

    Trend survey of physicians performed over 3 years

Study Arms (3)

Round 1

survey of 150 oncologists

Other: Physician Survey

Round 2

survey of 150 oncologists approximately 12 months after round 1

Other: Physician Survey

Round 3

survey of 150 oncologists approximately 24 months after round 1

Other: Physician Survey

Interventions

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 1Round 2Round 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Must not have taken part in this study previously
  • Must not have participated in Amgen study number 20101120.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

July 30, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 9, 2022

Record last verified: 2022-09