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

NCT03908788 | Active Not Recruiting DMC

• 1 other identifier: 2018-A00232-53
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

Metastatic Colorectal Cancer; Detection of the emergence of RAS mutations; Circulating DNA in patients; Treatment with anti-EGFR therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with mCRC (metastatic colorectal cancer) who develop a RAS (rat sarcoma viral oncogene homolog) mutation under anti-EGFR (epidermal growth factor receptor) therapy

  From baseline to the end of treatment

  Approximately 8 weeks

Secondary Outcomes (11)

• Probability of obtaining a positive test, i.e. RAS status mutated by the Intplex® test, among the patients determined RAS mutated by the tissue test

  Approximately 8 weeks

• Probability of obtaining a negative test, i.e. wild RAS status by the Intplex® test among patients determined wild RAS by the tissue test

  Approximately 8 weeks

• Probability of obtaining a positive test, i.e. BRAF status mutated by the Intplex® test, among the patients determined BRAF mutated by the tissue test

  Approximately 8 weeks

• Probability of obtaining a negative test, i.e. wild BRAF status by Intplex® test among patients determined wild BRAF by tissue test.compared to the pre-treatment tissue test

  Approximately 8 weeks

• Proportion of patients with a BRAF mutation under anti-EGFR therapy

  Approximately 8 weeks

Study Arms (1)

Intplex test

EXPERIMENTAL

In vitro diagnostic device

Device: Intplex test

Interventions

Intplex test DEVICE

Blood sample at each tumor assessment

Intplex test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (2)

ICM Val d'Aurelle

Montpellier, Montpellier, 34298, France

Location

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, 34298, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: April 9, 2019
• Study Start: July 26, 2018
• Primary Completion: December 3, 2023
• Study Completion: October 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)