Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

Metastatic Colorectal Cancer Clinical Trial

Official title:

Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791361
• Other study ID #: 20101120
• Status: Completed
• Start date: September 19, 2012
• Est. completion date: June 2, 2015

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 439
• Est. completion date: June 2, 2015
• Est. primary completion date: June 2, 2015
• 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 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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Other
No intervention other than routine medical care

Locations

Country	Name	City	State
Belgium	Research Site	Bonheiden
Belgium	Research Site	Brasschaat
Belgium	Research Site	Brugge
Belgium	Research Site	Haine Saint Paul - La Louviere
Belgium	Research Site	Liège
Belgium	Research Site	Merksem
Czechia	Research Site	Brno
Czechia	Research Site	Chomutov
Czechia	Research Site	Jihlava
Czechia	Research Site	Plzen
Czechia	Research Site	Praha 4
Czechia	Research Site	Usti nad Labem
Denmark	Research Site	Esbjerg
Denmark	Research Site	Herning
Denmark	Research Site	Hillerod
Denmark	Research Site	København
France	Research Site	Ajaccio
France	Research Site	Avignon
France	Research Site	Bordeaux Cedex
France	Research Site	Brest
France	Research Site	Clermont Ferrand cedex 1
France	Research Site	Evry cedex
France	Research Site	Grenoble Cedex 9
France	Research Site	La Tronche
France	Research Site	Limoges Cedex 1
France	Research Site	Lyon Cedex 08
France	Research Site	Marseille Cedex 08
France	Research Site	Muret Cedex
France	Research Site	Nancy
France	Research Site	Périgueux cedex
France	Research Site	Perpignan
France	Research Site	Reims
France	Research Site	Saint Grégoire cedex
France	Research Site	Strasbourg
France	Research Site	Toulouse
Germany	Research Site	Ahaus
Germany	Research Site	Amberg
Germany	Research Site	Arnsberg
Germany	Research Site	Aschersleben
Germany	Research Site	Bonn
Germany	Research Site	Dessau
Germany	Research Site	Duisburg
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Goslar
Germany	Research Site	Halle (Saale)
Germany	Research Site	Hamburg
Germany	Research Site	Köln
Germany	Research Site	Köln
Germany	Research Site	Leipzig
Germany	Research Site	Leverkusen
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Osnabrück
Germany	Research Site	Pforzheim
Germany	Research Site	Recklinghausen
Germany	Research Site	Regensburg
Germany	Research Site	Saarbrücken
Germany	Research Site	Wilhelmshaven
Italy	Research Site	Foggia
Italy	Research Site	Legnago VR
Italy	Research Site	Napoli
Italy	Research Site	Ravenna
Italy	Research Site	Roma
Italy	Research Site	Torino
Italy	Research Site	Vimercate MB
Netherlands	Research Site	Amstelveen
Netherlands	Research Site	Doetinchem
Netherlands	Research Site	Eindhoven
Spain	Research Site	Bilbao	País Vasco
Spain	Research Site	Burgos	Castilla León
Spain	Research Site	Castellon	Comunidad Valenciana
Spain	Research Site	Granollers	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Ourense	Galicia
Spain	Research Site	Oviedo	Asturias
Spain	Research Site	Palma de Mallorca	Baleares
Spain	Research Site	Pamplona	Navarra
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Göteborg
Sweden	Research Site	Karlskrona
Sweden	Research Site	Skövde
Sweden	Research Site	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden, 

References & Publications (1)

Han van Krieken J, Kafatos G, Bennett J, Mineur L, Tomášek J, Rouleau E, Fabian P, De Maglio G, García-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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The proportion of patients with mCRC treated with Vectibix only or treated with Vectibix and concurrently treated with oxaliplatin-containing chemotherapy who received a KRAS test to determine tumor KRAS status prior to treatment with Vectibix, and characterize the results of above testing for KRAS testing: proportion that are mutant, wild-type or unknown but tested	3 years
Secondary	The proportion of oncologists who agree to participate in the study		3 years
Secondary	The proportion of oncologists that conduct a KRAS testing prior to Vectibix prescription in patients with mCRC treated with Vectibix		3 years
Secondary	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	The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.	3 years
Secondary	The proportion of laboratories that use a CE-marked or otherwise validated KRAS detection method	The study will obtain data from laboratories that tested KRAS status on mCRC patients who were treated with Vectibix.	3 years
Secondary	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		3 years

External Links

•   AmgenTrials clinical trials website