BRAF V600E Mutation PositiveCAPSTAN CRCNCT04317599
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
An observational study of BRAF V600E Mutation Positive and Metastatic Colorectal Cancer, run by Pierre Fabre Medicament at 34 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BRAF V600E Mutation Positive, Metastatic Colorectal Cancer
- What is being tested?
- Non interventional
- How many people
- 274 participants
- Where
- 34 sitesin 7 countries
- Study dates
- 12 Apr 2020to 12 May 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
34 sites in 7 countries.
34 sites in 7 countries
France8 sites
CHRU de Besançon
Besançon
GHPSO (Groupe Hospitalier Sud de l'Oise)
Creil
CHU Grenoble Alpes
La Tronche
Hôpital Franco-Britannique
Levallois-Perret
Centre Oscar Lambert
Lille
ICM Val d'Aurelle
Montpellier
CHU de Poitiers
Poitiers
Gustave Roussy
Villejuif
Germany7 sites
Klinikum Aschaffenburg Medical Klinik IV
Aschaffenburg
Studienzentrale Gokos
Dresden
Universitätsklinikum Essen
Essen
Facharztzentrum Eppendorf
Hamburg
Oncoresearch Lerchenfeld
Hamburg
MVZ Mitte Leipzig
Leipzig
MZ Onkologie Velbert/Ratingen/Mettmann
Velbert
Italy6 sites
Clinica Oncologica Ospedali Riuniti di Ancona
Ancona
Santa Maria Goretti Hospital
Latina
Instituto Nazionale Tumori, IRCCS, Fondazione G. Pascale
Naples
Azienda Ospedaliero-Universitaria Pisana
Pisa
AUSL-IRCCS of Reggio Emilia-Clinical Cancer Center
Reggio Emilia
Asst Valle Olona
Saronno
Belgium4 sites
Imelda VZW
Bonheiden
AZ Klina
Brasschaat
UZ Leuven
Leuven
CHC MontLégia
Liège
United Kingdom4 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Harrogate & District NHS Foundation Trust
Harrogate
Imperial College Healthcare NHS Trust
London
University College London Hospitals NHS Foundation Trust
London
Spain3 sites
Hospital del Mar
Barcelona
La Paz University Hospital
Madrid
Hospital General Universitario de Valencia
Valencia
Austria2 sites
Barmherzige Brüder Krankenhaus St. Veit/Glan.
Saint Veit/Glan
Medizinische Universität Wien
Vienna
About this study
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.
Read the 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.
- Being tested
- Non interventional
- Keywords
- first line, retrospective study, mCRC, BRAF V600E
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionalOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Non interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received
Measured: time from treatment initiation (for mCRC) up to 31 December 2020
Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by Duration of Treatment
Measured: time from treatment initiation (for mCRC) up to 31 December 2020
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Switch in mCRC first-line SACT treatment in BRAFV600E mutant mCRC patients.
Measured: time from treatment initiation (for mCRC) up to 31 December 2020
Secondary outcomes (7)
Demographic and Clinical Characteristics
Description of the demographic and clinical profile of patients at the time of treatment initiation (for mCRC) TNM stage of colorectal cancer. Stage I: Cancer is still in the inner lining, but has grown through the mucosa of the colon and invaded the muscle layer.
Stage II: The cancer has grown beyond the mucosa of the colon but has not spread to the lymph nodes Stage III: The cancer has spread to the lymph nodes near the colon, it has not spread further.
Stage IV: The cancer has spread outside of the colon and has been carried through the lymph and blood systems to distant parts of the body, this is known as metastasis.
Measured: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Progression-free Survival (PFS)
the length of time between initiation of first-line treatment for mCRC and the first documented disease progression or death.
Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Overall Survival (OS)
length of time between first-line treatment initiation (for mCRC) and death (due to any cause)
Measured: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Overall Response Rate (ORR)
complete response (CR) or partial response (PR), during the first line treatment Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 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
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)
Measured: from the date of the start of first-line treatment for mCRC until the documented disease progression up to 31 December 2020
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Description of testing procedures of BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC
Measured: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
Time to BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC
Measured: from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start12 Apr 2020
- Primary completion4 Mar 2021
- Study completion12 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BRAF V600E Mutation PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact
- Responsible party
- Sponsor
- Investigators
- Bernard Asselain, MD, PhD, Study chairDirk Arnold, MD, PhD, Study chairErika Martinelli, MD, PhD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317599
- Sponsor's protocol ID
- NIS-PF0-2020-3141
- Acronym
- CAPSTAN CRC
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2020
- Last updated
- 2 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
- ClinicalTrials.gov ID
- NCT04317599
- Acronym / sponsor ID
- CAPSTAN CRC / NIS-PF0-2020-3141
- Keywords
- first line, retrospective study, mCRC, BRAF V600E
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- Clinact
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 23 Mar 2020 (actual)
- Results
- Posted 15 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non interventional | – | Other: Non interventionalAll 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionalAll 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 |
Primary outcome
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Time frame: time from treatment initiation (for mCRC) up to 31 December 2020
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by agent or combination of agents received
Duration of Treatment for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients
Time frame: time from treatment initiation (for mCRC) up to 31 December 2020
First-line SACT treatment patterns in BRAFV600E mutant mCRC patients described by Duration of Treatment
Switch in mCRC First-line Systemic Anticancer Therapy (SACT) Treatment in BRAFV600E Mutant mCRC Patients
Time frame: time from treatment initiation (for mCRC) up to 31 December 2020
Switch in mCRC first-line SACT treatment in BRAFV600E mutant mCRC patients.
7 secondary outcomes
Demographic and Clinical Characteristics
Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Progression-free Survival (PFS)
Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020
Overall Survival (OS)
Time frame: from the date of the start of first-line treatment for mCRC 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
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
Description of BRAF Mutation Testing Procedure in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
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
Description of BRAF Mutation Testing Timing in Regards With the First-line Treatment in BRAFV600E Mutant mCRC Patients
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Asselain, MD, PhD study chair
Dirk Arnold, MD, PhD study chair
Erika Martinelli, MD, PhD study chair
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BRAF V600E Mutation Positive and Metastatic Colorectal Cancer, run by Pierre Fabre Medicament at 34 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France, Germany, Italy, Belgium, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Patterns for First-line Systemic Anticancer Therapy (SACT) in BRAFV600E Mutant mCRC Patients (time frame: time from treatment initiation (for mCRC) up to 31 December 2020). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.