Clinical trial NCT01791361: Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
Official title: Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: Metastatic colorectal cancer
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 439
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Oncologists satisfying all of the physician eligibility criteria will be eligible to participate in the medical records review study. From each eligible oncologist, medical records from 3 or more patients who satisfy all the patient inclusion criteria will be obtained.

Brief summary: This non-interventional retrospective medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

Detailed description: The medical record review will be conducted for 3 rounds in months 0, 12, and 24 after the first medical record abstraction. Before the beginning of the study, a sampling list will be created by Amgen by merging lists of oncologists (and their contact information) to be collected from Cegedim, the ESMO, from major cancer centers and oncology clinics in various countries within Europe. In each round of medical record review, potential participating oncologists will be randomly sampled from all identified oncologists. Potential oncologists will be contacted by letter, telephone or email. The oncologists will be introduced to the study, and their eligibility to participate in the study will be assessed using a standardized questionnaire. The number of oncologists sampled per country will be proportional to the number of oncology centers per country. Approximately 50 oncologists will participate in each round of the study. From each eligible participating oncologist, study staff will then obtain approximately 3 or more medical records for patients who have received Vectibix for the treatment of mCRC during the 6-month period prior to the time of contact with the relevant oncologist and are not involved in an experimental clinical trial when treated with Vectibix. A written consent may be obtained from participating patients to access their medical records, depending on local laws. Medical information will be abstracted from the medical records using standardized forms. Such medical information will include the occurrence and timing of treatment with Vectibix and oxaliplatin-containing chemotherapy, diagnosis of mCRC and the occurrence, timing and results of KRAS testing. The oncologist will also be asked to collect information from the pathology laboratory that performed the KRAS mutation test on the patient, using a standardized pathology data extraction form.

Eligibility criteria: Physician Inclusion Criteria:

* Must be a practicing oncology specialist
* Must treat at least 5 new or continuing patients with metastatic colorectal cancer per quarter
* Must have prescribed Vectibix to treat at least 5 new or continuing patients with metastatic colorectal cancer in the past 6 months

Physician Exclusion Criteria:

* Must be the only oncologist sampled at the same medical centre for that round of the study
* Must not have taken part in the study previously

Patient Inclusion Criteria

* Must have received Vectibix for the treatment of metastatic colorectal cancer during the 6-month period prior to the time when medical records are obtained
* Must not have been in any experimental clinical trial at the time of receiving Vectibix
* Must provide written consent to allow access to their medical records (if local laws require it)
* Must not have taken part in the study before

Primary outcomes:
measure: The prevalence of KRAS testing and impact of the KRAS test results on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix
timeFrame: 3 years
Secondary outcomes:
measure: The proportion of oncologists who agree to participate in the study
timeFrame: 3 years
measure: The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix
timeFrame: 3 years
measure: The proportion of laboratories that participate in the European Society of Pathology (ESP) Quality Assurance Scheme or are certified by an ESP approved accreditation body
timeFrame: 3 years
measure: The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method
timeFrame: 3 years
measure: To characterize the results of KRAS testing in the three rounds of chart abstraction that will be carried out at 0, 12 and 24 months to indicate if there are any differences in results from each of the three rounds
timeFrame: 3 years
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Haine Saint Paul - La Louviere
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Merksem
country: Belgium
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Chomutov
country: Czechia
facility: Research Site
city: Jihlava
country: Czechia
facility: Research Site
city: Plzen
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Usti nad Labem
country: Czechia
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hillerod
country: Denmark
facility: Research Site
city: København
country: Denmark
facility: Research Site
city: Ajaccio
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Bordeaux Cedex
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Clermont Ferrand cedex 1
country: France
facility: Research Site
city: Evry cedex
country: France
facility: Research Site
city: Grenoble Cedex 9
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: Limoges Cedex 1
country: France
facility: Research Site
city: Lyon Cedex 08
country: France
facility: Research Site
city: Marseille Cedex 08
country: France
facility: Research Site
city: Muret Cedex
country: France
facility: Research Site
city: Nancy
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Périgueux cedex
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Saint Grégoire cedex
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Ahaus
country: Germany
facility: Research Site
city: Amberg
country: Germany
facility: Research Site
city: Arnsberg
country: Germany
facility: Research Site
city: Aschersleben
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Dessau
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Goslar
country: Germany
facility: Research Site
city: Halle (Saale)
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Osnabrück
country: Germany
facility: Research Site
city: Pforzheim
country: Germany
facility: Research Site
city: Recklinghausen
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Saarbrücken
country: Germany
facility: Research Site
city: Wilhelmshaven
country: Germany
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Legnago VR
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Vimercate MB
country: Italy
facility: Research Site
city: Amstelveen
country: Netherlands
facility: Research Site
city: Doetinchem
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Baleares
city: Burgos
country: Spain
facility: Research Site
state: Castilla León
city: Granollers
country: Spain
facility: Research Site
state: Cataluña
city: Castellon
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Ourense
country: Spain
facility: Research Site
state: Galicia
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Bilbao
country: Spain
facility: Research Site
state: País Vasco
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Eskilstuna
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Karlskrona
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Han van Krieken J, Kafatos G, Bennett J, Mineur L, Tomasek J, Rouleau E, Fabian P, De Maglio G, Garcia-Alfonso P, Aprile G, Parkar P, Downey G, Demonty G, Trojan J. Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review. BMC Cancer. 2017 Nov 28;17(1):798. doi: 10.1186/s12885-017-3740-4.