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NCT Number: NCT04317599

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

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.

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Key information

Conditions

BRAF V600E Mutation Positive Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Colorectal Cancer Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barmherzige Brüder Krankenhaus St. Veit/Glan., Saint Veit/Glan, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non Interventional

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. Demographic and Clinical Characteristics

    Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020

    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.

  2. Progression-free Survival (PFS)

    Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020

    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.

  3. Overall Survival (OS)

    Time frame: from the date of the start of first-line treatment for mCRC up to 31 December 2020

    length of time between first-line treatment initiation (for mCRC) and death (due to any cause)

  4. 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

    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

  5. 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)

  6. 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 testing procedures of BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC

  7. 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

    Time to BRAF mutation testing since mCRC diagnosis and since first-line treatment for mCRC

Other outcomes

  1. Reasons for Alteration or Discontinuation of 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 reasons for alteration or discontinuation of first-line treatment for mCRC in BRAFV600E Mutant mCRC Patients

  2. Other Types of SACT Treatment Line Regiments After First-line Treatment for mCRC 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 the types of treatments after first-line SACT treatment (2nd-line to 7th-line) in BRAFV600E Mutant mCRC Patients.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Collaborators

  • Clinact

Registry information

Acronym: CAPSTAN CRC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2020
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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