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

January 20, 2023 updated by: Pierre Fabre Medicament

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with BRAFV600E mutant mCRC (determined by local laboratory result) in the target countries and initiating first line treatment between January 1st, 2016 and December 31st, 2018 (both days inclusive) will be eligible for enrollment into the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non interventional
All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between 01 January, 2016 and 31 December, 2018 (both days inclusive) with drugs registered for mCRC in respective country
Other: Non Interventional study
Non Interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First-line Systemic anticancer therapy (SACT) treatment patterns in BRAFV600E mutant mCRC patients
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic and clinical characteristics
Time Frame: 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
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
Progression-free Survival (PFS)
Time Frame: 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
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
Overall Survival (OS)
Time Frame: 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
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
Overall Response rate (ORR)
Time Frame: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
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
Time to treatment cessation
Time Frame: from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Collaborators

Clinact

Investigators

  • Study Chair: Bernard Asselain, MD, PhD
  • Study Chair: Dirk Arnold, MD, PhD
  • Study Chair: Erika Martinelli, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2020

Primary Completion (Actual)

March 4, 2021

Study Completion (Actual)

May 12, 2021

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-PF0-2020-3141

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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