Actively Recruiting
Encorafenib and Cetuximab in Patients With Metastatic, BRAFV600E-mutated Colorectal Carcinoma: A Multi-center, Multi-national, Prospective, Longitudinal, Non-interventional Study in Germany, Austria and Switzerland
Led by Pierre Fabre Pharma GmbH · Updated on 2022-09-29
500
Participants Needed
70
Research Sites
17 weeks
Total Duration
On this page
Sponsors
P
Pierre Fabre Pharma GmbH
Lead Sponsor
I
iOMEDICO AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying metastatic colorectal carcinoma (mCRC) patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.
CONDITIONS
Brief Title
BRAF Inhibitor Encorafenib And Cetuximab Real Life Investigation of Next Generation CRC Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has provided written informed consent for pseudonymized data documentation
- Patient is legally capable and 18 years of age or older
- Diagnosis of metastatic colorectal carcinoma with BRAFV600E mutation
- Patient has been pretreated with systemic therapy
- Decision to treat with encorafenib plus cetuximab was made prior to and independent of study inclusion
- Treatment with encorafenib plus cetuximab started within 3 months prior to consent or is planned soon
You will not qualify if you...
- More than 2 prior systemic regimens for metastatic disease
- Prior treatment with any RAF-inhibitor or MEK-inhibitor
- Any contraindications for encorafenib plus cetuximab as per product information
- Current or planned participation in an interventional clinical trial
- Current or planned systemic treatment for any tumor other than metastatic colorectal carcinoma
- Prisoners or involuntarily detained individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 months of treatment exposure
Participants who undergo routine care with encorafenib and cetuximab are observed for effectiveness, safety, and quality of life.
Visits as per routine clinical care throughout treatment
Duration - Up to 12 months after start of treatment
Participants are followed for overall survival and ongoing safety assessments after treatment completion.
Follow-up visits as per routine care
Trial Site Locations
Total: 70 locations
1
Clinic
Braunau am Inn, Upper Austria, Austria, 5280
Actively Recruiting
2
Clinic
Linz, Upper Austria, Austria, 4010
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3
Clinic
Feldkirch, Voralberg, Austria, 6807
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4
Clinic
Vienna, Austria, 1090
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5
Practice
Offenburg, Baden-Wurttemberg, Germany, 77654
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6
Medical Care Centre
Ulm, Baden-Wurttemberg, Germany, 89073
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7
Clinic
Ulm, Baden-Wurttemberg, Germany, 89081
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8
Practice
Augsburg, Bavaria, Germany, 86150
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9
Practice
Donauwörth, Bavaria, Germany, 86609
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10
Clinic
Erlangen, Bavaria, Germany, 91054
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11
Practice
München, Bavaria, Germany, 81241
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12
Practice
Würzburg, Bavaria, Germany, 97080
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13
Medical Car Centre
Aschaffenburg, Bayer, Germany, 63739
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14
Medical Care Centre
Potsdam, Brandenburg, Germany, 14467
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15
Practice
Celle, Lower Saxony, Germany, 29221
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16
Medical Care Centre
Goslar, Lower Saxony, Germany, 38642
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17
Practice
Göttingen, Lower Saxony, Germany, 37073
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18
Medical Practice
Hanover, Lower Saxony, Germany, 30161
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19
Practice
Hanover, Lower Saxony, Germany, 30161
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20
Practice
Leer, Lower Saxony, Germany, 26789
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21
Clinic
Weißenfels, Lower Saxony, Germany, 26121
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22
Medical Practice
Wilhelmshaven, Lower Saxony, Germany, 26389
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23
Practice
Rostock, Mecklenburg-Vorpommern, Germany, 18057
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24
Practice
Rostock, Mecklenburg-Vorpommern, Germany, 18107
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25
Clinic
Rostock, Melcklenburg-Vorpommern, Germany, 18059
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26
Clinic
Aachen, North Rhine-Westphalia, Germany, 52074
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27
Clinic
Bochum, North Rhine-Westphalia, Germany, 44791
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28
Practice
Bonn, North Rhine-Westphalia, Germany, 53123
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29
Clinic
Bonn, North Rhine-Westphalia, Germany, 53127
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30
Practice
Bottrop, North Rhine-Westphalia, Germany, 46236
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31
Clinic
Essen, North Rhine-Westphalia, Germany, 45147
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32
Practice
Moers, North Rhine-Westphalia, Germany, 47441
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33
Medical Care Centre
Mönchengladbach, North Rhine-Westphalia, Germany, 41239
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34
Medical Care Centre
Mülheim, North Rhine-Westphalia, Germany, 45468
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35
Medical Care Centre
Neuss, North Rhine-Westphalia, Germany, 41462
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36
Clinic
Paderborn, North Rhine-Westphalia, Germany, 33098
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37
Medical Care Centre
Porta Westfalica, North Rhine-Westphalia, Germany, 32457
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38
Practice
Stolberg, North Rhine-Westphalia, Germany, 52222
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39
Practice
Troisdorf, North Rhine-Westphalia, Germany, 53840
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40
Clinic
Wuppertal, North Rhine-Westphalia, Germany, 42283
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41
Practice
Bad Kreuznach, Rhineland-Palatinate, Germany, 55543
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42
Practice
Kaiserslautern, Rhineland-Palatinate, Germany, 67655
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43
Practice
Worms, Rhineland-Palatinate, Germany, 67547
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44
Clinic
Saarbrücken, Saarland, Germany, 66113
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45
Practice
Dresden, Saxony, Germany, 01307
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46
Prctice
Naunhof, Saxony, Germany, 04683
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47
Clinic
Torgau, Saxony, Germany, 04860
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48
Practice
Halle, Saxony-Anhalt, Germany, 06110
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49
Clinic
Köthen, Saxony-Anhalt, Germany, 06366
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50
Practice
Köthen, Saxony-Anhalt, Germany, 06366
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51
Clinic
Flensburg, Schleswig-Holstein, Germany, 24939
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52
Clinic
Eisenach, Thuringia, Germany, 99817
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53
Hospital
Aschaffenburg, Germany
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54
Medical Care Centre
Berlin, Germany, 10407
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55
Practice
Berlin, Germany, 10707
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56
Practice
Berlin, Germany, 10715
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57
Clinic
Berlin, Germany, 12559
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58
Private Practice
Berlin, Germany
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59
Private Practice
Dresden, Germany
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60
Hospital
Esslingen am Neckar, Germany
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61
Practice
Hamburg, Germany, 10259
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62
Practice
Hamburg, Germany, 20259
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63
Private Practice
Heidelberg, Germany
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64
Private Practice
Leer, Germany
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65
Private Practice
Lübeck, Germany
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66
Private Practice
Naunhof, Germany
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67
Private Practice
Offenburg, Germany
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68
Private Practice
Oldenburg in Holstein, Germany
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69
Private Practice
Schorndorf, Germany
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70
Private Practice
Würzburg, Germany
Actively Recruiting
Research Team
M
Marion Schmoll
F
Frank Reichenbach, Dr. rer. nat
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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