Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With mCRC (Metastatic Colorectal Cancer) During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy
NCT ID: NCT03908788
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
130 participants
INTERVENTIONAL
2018-07-26
2025-10-31
Brief Summary
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EmutRAS is one of the first studies that will specifically and prospectively evaluate the RAS mutational switch and its impact on the efficiency of the 1st line processing.
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Detailed Description
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The treatment and these modalities will be decided by the investigator.
The study is based on blood sampling, the frequency of which is described below, rhythm of plasma samples:
Inclusion after determination of wild status RAS tissues.
First sampling of 2 EDTA (ethylenediaminetetraacetic acid) tubes, then at each tumour evaluation during treatment with anti EGFR (epidermal growth facor receptor), every 4 cures. At the end of treatment or after more than 36 treatment cures, a final sample will be taken.
No results of the samples will be communicated to the investigator, the sponsor will centralize these results for the final analysis of the study.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intplex test
In vitro diagnostic device
Intplex test
Blood sample at each tumor assessment
Interventions
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Intplex test
Blood sample at each tumor assessment
Eligibility Criteria
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Inclusion Criteria
* Patient treated in the first line by one of the treatments below and according to a bi-monthly schema for cetuximab: FOLFIRI (elvorin + 5 Fluorouracil + irinotecan) ou FOLFOX (elvorin + 5 Fluorouracil + oxalplatin) + Cetuximab\* (Erbitux) ; FOLFIRI ou FOLFOX + Panitumumab (Vectibix); FOLFIRINOX ou FOLFOXIRI ((elvorin + 5 Fluorouracil + oxaliplatin + irinotecan) + Cetuximab\* (Erbitux); FOLFIRINOX ou FOLFOXIRI + Panitumumab (Vectibix) For patient treated cetuximab administration will be bi-monthly
* Patient with at least one evaluable metastatic target according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
* Wild RAS (rat sarcoma viral oncogene homolog) status detected by standard tissue test, on primary tumor and / or metastasis
* Wild BRAF (murine sarcoma viral oncogene homolog B) status detected by standard tissue test, on primary tumor and / or metastasis
* Man or woman\> 18 years old
* Signed informed consent before any specific procedure to study
* Patient affiliated to the social security or equivalent
Exclusion Criteria
* Patient with a multifocal primary tumor
* RAS (rat sarcoma viral oncogene homolog) status mutated or not detectable on tissue analysis
* BRAF (murine sarcoma viral oncogene homolog B) status mutated or undetectable on tissue analysis
* Patient receiving adjuvant chemotherapy or radiotherapy within \<14 days
* History of other cancer in the last 5 years (except in-situ carcinoma of the cervix and cutaneous carcinoma excluding melanoma treated optimally)
* Blood transfusion (whole blood, red blood cell, platelets...) in the previous week
* Patients with psychological, familial, sociological or geographic conditions potentially not favorable to the good observance of the study protocol and the follow-up
* Legal incapacity or limited legal capacity
Participation in another interventional clinical trial - biomedical research (therapeutic strategy type) is not excluded provided that it is use an Anti-EGFR with a AMM (marketing authorization), (Cetuximab - Panitumumab) with a dose and a standard administration rhythm (according to the AMM).
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Locations
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ICM Val d'Aurelle
Montpellier, Montpellier, France
Institut du Cancer de Montpellier - Val d'Aurelle
Montpellier, , France
Countries
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Other Identifiers
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2018-A00232-53
Identifier Type: -
Identifier Source: org_study_id
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