NCT03908788Active, not recruiting
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
Detection of the Emergence of RAS (Rat Sarcoma Viral Oncogene Homolog) Mutations in Circulating DNA (Deoxyribonucleic Acid) in Patients With Metastatic Colorectal Cancer During Treatment With Anti-EGFR (Epidermal Growth Factor Receptor) Therapy
Source: ClinicalTrials.gov · Last updated 16 Apr 2025
Brief summary (registry, in English)
The analysis of circulating DNA (Deoxyribonucleic acid) to identify potential resistance mechanisms during anti-EGFR (epidermal growth factor receptor) treatment is of great interest, as evidenced by the recent journal published by Corcoran in the prestigious New England Journal of Medicine. 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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 25 Jan 2019
- Start date
- 26 Jul 2018
- Primary completion date
- 3 Dec 2023
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Diseases
- Colorectal cancer, Sarcoma
- NCT number
- NCT03908788
What you commit to
- Study type: Interventional
- Planned participants: 130
- From 26 Jul 2018 to the primary completion date, 3 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient receiving adjuvant chemotherapy or radiotherapy within \<14 days
Other illness
- History of other cancer in the last 5 years (except in-situ carcinoma of the cervix and cutaneous carcinoma excluding melanoma treated optimally)
- Patients with psychological, familial, sociological or geographic conditions potentially not favorable to the good observance of the study protocol and the follow-up
Lab values
- Previous treatment with an anti-EGFR (epidermal growth factor receptor)
- Blood transfusion (whole blood, red blood cell, platelets...) in the previous week
- 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).
Other
- 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
Who the study is looking for
- Patient with histologically confirmed metastatic colorectal cancer
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICM Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Institut du Cancer de Montpellier - Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.