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 (EmutRAS)

  • STATUS
    Recruiting
  • End date
    Oct 25, 2024
  • participants needed
    130
  • sponsor
    Institut du Cancer de Montpellier - Val d'Aurelle
Updated on 25 March 2022
growth factor
fluorouracil
metastasis
oxaliplatin
panitumumab
EGFR
irinotecan
primary tumor
cetuximab
solid tumour
folfiri regimen
folfirinox
folfoxiri
rat sarcoma

Summary

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.

Description

The primary study objective is the Detection of RAS mutational (rat sarcoma viral oncogene homolog) "switch" in circulating DNA by Intplex® test in mCRC (metastatic colorectal cancer) patients treated with antibody anti-EGFR (epidermal growth factor receptor), cetuximab or panitumumab in first line.

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.

Details
Condition Metastatic Colorectal Cancer
Treatment Intplex test
Clinical Study IdentifierNCT03908788
SponsorInstitut du Cancer de Montpellier - Val d'Aurelle
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Previous treatment with an anti-EGFR (epidermal growth factor receptor)
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note