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

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: Metastatic Colorectal Cancer; BRAF V600E Mutation Positive
• Intervention / Treatment: Other: Non interventional

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

Study Locations

• Austria
  • Saint 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 MontLégia
• France
  • Besançon, France
    • CHRU De Besancon
  • Creil, France
    • GHPSO (Groupe Hospitalier Sud de l'Oise)
  • La Tronche, France
    • Chu Grenoble Alpes
  • Levallois-Perret, France
    • Hôpital 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
    • Universitätsklinikum 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
  • Valencia, 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

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	time from treatment initiation (for mCRC) up to 31 December 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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	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)	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	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	from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for Alteration or Discontinuation of First-line Treatment in BRAFV600E Mutant mCRC Patients	Description of reasons for alteration or discontinuation of first-line treatment for mCRC in BRAFV600E Mutant mCRC Patients	from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020
Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC in BRAFV600E Mutant mCRC Patients	Description of the types of treatments after first-line SACT treatment (2nd-line to 7th-line) in BRAFV600E Mutant mCRC Patients.	from the date of the start of first-line treatment for mCRC until the end of first-line treatment up to 31 December 2020

Collaborators and Investigators

• 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

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 (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: first line; BRAF V600E; mCRC; retrospective study
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• 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