Status:
RECRUITING
BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Lead Sponsor:
Pierre Fabre Pharma GmbH
Collaborating Sponsors:
iOMEDICO AG
Pierre Fabre Pharma AG
Conditions:
Metastatic Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Brief Summary
The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 month...
Detailed Description
The presence of a BRAFV600E mutation is a marker of poor prognosis in patients with mCRC and associated with a median overall survival (mOS) of approximately 12 to 14 months compared to 20 to 25 month...
Eligibility Criteria
Inclusion
- Written informed consent of the patient with regard to the pseudonymized documentation of his/her data in the frame of this non-interventional study
- Legally capable patient ≥ 18 years of age (no upper limit)
- Metastatic colorectal carcinoma with BRAFV600E-mutation, pretreated with systemic therapy
- Decision was taken to treat the patient with the doublet therapy (encorafenib and cetuximab) in accordance with the current SmPC and by prescription; this decision was taken prior to and independent from the inclusion into the study;
- Treatment with the doublet therapy (encorafenib plus cetuximab) has been started ≤ 3 months prior to providing written informed consent for this study or is planned to be started in the near future.
Exclusion
- More than 2 prior systemic regimens in the metastatic setting (adjuvant systemic therapy with relapse ≤ 6 months will be counted as metastatic treatment line; maintenance treatment will not be counted as separate metastatic treatment line)
- Prior treatment with any RAF-inhibitor or MEK-inhibitor.
- Presence of any contraindication with regard to the doublet therapy (encorafenib plus cetuximab) as specified in the corresponding SmPCs
- Current or upcoming participation in an interventional clinical trial
- Current or upcoming systemic treatment of any other tumor than metastatic colorectal carcinoma
- Prisoners or persons who are compulsorily detained (involuntarily incarcerated).
Key Trial Info
Start Date :
September 3 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04673955
Start Date
September 3 2020
End Date
January 1 2027
Last Update
September 29 2022
Active Locations (70)
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1
Clinic
Braunau am Inn, Upper Austria, Austria, 5280
2
Clinic
Linz, Upper Austria, Austria, 4010
3
Clinic
Feldkirch, Voralberg, Austria, 6807
4
Clinic
Vienna, Austria, 1090