A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

Metastatic Colorectal Cancer Clinical Trial

— CAPSTAN CRC  

Official title:

A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317599
• Other study ID #: NIS-PF0-2020-3141
• Status: Completed
• Start date: April 12, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: January 2023
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

Description:

This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st, 2016 and December 31st, 2018 (both days inclusive) with drugs registered for mCRC in respective country will be eligible to participate. The study will not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment. The target countries for patient enrollment will include Germany, France, Italy, United Kingdom, Spain, Belgium, Austria and the Netherlands. Approximately 300 adult patients (≥18 years) from a mix of academic and non-academic sites (up to 65 sites) will be enrolled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: May 12, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
• Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay
• Initiated first-line treatment with drugs registered for mCRC in the respective country at the time of treatment between January 1st, 2016 and December 31st, 2018 (both days inclusive)
• Provision of informed consent or non-opposition to the patient (or next of kin, if applicable) for the use of data, according to local regulations Exclusion Criteria:

Patients will be excluded from the study if they fulfil any of the following criteria:

• Patients with another concomitant cancer at the time of diagnosis*
• Patients participating in interventional trials on investigational drugs at the time of initiation of first-line treatment
• Except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of mCRC diagnosis.

Related Conditions & MeSH terms

• BRAF V600E Mutation Positive
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Non Interventional study
Non Interventional study

Locations

Country	Name	City	State
Austria	Barmherzige Brüder Krankenhaus St. Veit/Glan.	St. Veit/Glan
Austria	Medizinische Universität Wien	Vienna
Belgium	Imelda VZW	Bonheiden
Belgium	AZ Klina	Brasschaat
Belgium	UZ Leuven	Leuven
Belgium	CHC MontLégia	Liège
France	CHRU de Besançon	Besançon
France	GHPSO (Groupe Hospitalier Sud de l'Oise)	Creil
France	CHU Grenoble Alpes	La Tronche
France	Hôpital Franco-Britannique	Levallois-Perret
France	Centre Oscar Lambert	Lille
France	ICM Val d'Aurelle	Montpellier
France	CHU de Poitiers	Poitiers
France	Gustave Roussy	Villejuif
Germany	Klinikum Aschaffenburg Medical Klinik IV	Aschaffenburg
Germany	Studienzentrale Gokos	Dresden
Germany	Universitätsklinikum Essen	Essen
Germany	Facharztzentrum Eppendorf	Hamburg
Germany	Oncoresearch Lerchenfeld	Hamburg
Germany	MVZ Mitte Leipzig	Leipzig
Germany	MZ Onkologie Velbert/Ratingen/Mettmann	Velbert
Italy	Clinica Oncologica Ospedali Riuniti di Ancona	Ancona
Italy	Santa Maria Goretti Hospital	Latina
Italy	Instituto Nazionale Tumori, IRCCS, Fondazione G. Pascale	Napoli
Italy	Azienda Ospedaliero-Universitaria Pisana	Pisa
Italy	AUSL-IRCCS of Reggio Emilia-Clinical Cancer Center	Reggio Emilia
Italy	Asst Valle Olona	Saronno
Spain	Hospital del Mar	Barcelona
Spain	La Paz University Hospital	Madrid
Spain	Hospital General Universitario de Valencia	Valence
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Harrogate & District NHS Foundation Trust	Harrogate
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Pierre Fabre Medicament	Clinact

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First-line Systemic anticancer therapy (SACT) treatment patterns in BRAFV600E mutant mCRC patients	Agent or combination of agents received, Duration of treatment, Maintenance therapy (if any)	time of treatment initiation (for mCRC) until the time of first documented disease progression, treatment discontinuation or switch, whichever is earlier or end of study observation period up to 31 December 2020
Secondary	Demographic and clinical characteristics	Description of the demographic and clinical profile of patients at the time of treatment initiation (for mCRC)	from the date of the start of first-line treatment for mCRC until the end of the observation period (date of death or last day of study observation period for patients alive at the time of data abstraction) up to 31 December 2020
Secondary	Progression-free Survival (PFS)	the length of time between initiation of first-line treatment for mCRC and the first documented disease progression	from the date of the start of first-line treatment for mCRC until the end of the observation period (date of death or last day of study observation period for patients alive at the time of data abstraction) up to 31 December 2020
Secondary	Overall Survival (OS)	length of time between first-line treatment initiation (for mCRC) and death (due to any cause)	from the date of the start of first-line treatment for mCRC until the end of the observation period (date of death or last day of study observation period for patients alive at the time of data abstraction) up to 31 December 2020
Secondary	Overall Response rate (ORR)	number of complete response (CR) or partial response (PR)	from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
Secondary	Time to treatment cessation	the length of time between initiation of first-line treatment for mCRC and documented disease progression (or start of subsequent Line Of Treatment (LOT), if disease progression is not well documented in patient medical record), treatment discontinuation or switch to another treatment (defined as change from one treatment regimen to another treatment regimen, e.g., change from FOLFOX-based regimen to FOLFIRI or irinotecan-based regimen)	from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020