Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer

NCT ID: NCT02872779

Last Updated: 2026-01-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-18

Study Completion Date

2020-08-10

Brief Summary

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The chemotherapy monitoring is currently based on radiological (RECIST 1.1 guideline) and clinical evaluation every 3 months. Circulating markers as Carcino Embryonic Antigen (CEA), circulating tumour DNA and total cell free DNA represent an alternative approach to evaluate the response. In the field of metastatic colorectal cancer (mCRC) recent studies suggest that early evaluation could be clinically relevant. Indeed, early tumoral response seems to be correlated to overall survival. Moreover, post-operative morbidity increases with the number of prior chemotherapy treatments. Early evaluation could allow to modify chemotherapy regimens when response appears to be insufficient.

The aim of the present study is to evaluate, in a prospective cohort of patients treated with systemic IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy as first line treatment for a mCRC, the correlation between early variations of circulating tumour markers including CEA, circulating tumour DNA and total cell free DNA, and the 3 months objective response as defined in the RECIST 1.1 guideline.

Detailed Description

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Conditions

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Circulating Markers Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Study Groups

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Patients Treated for Metastatic Colorectal cancer

Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer

Group Type EXPERIMENTAL

Blood sampling for free mutant DNA analysis

Intervention Type PROCEDURE

Blood sampling for Patients Treated for Metastatic Colorectal cancer

Interventions

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Blood sampling for free mutant DNA analysis

Blood sampling for Patients Treated for Metastatic Colorectal cancer

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male or female, age superior to 18 years.
* Histologically confirmed metastatic colorectal adenocarcinoma.
* Measurable disease according to the RECIST 1.1 guideline
* ECOG performance status \<3.
* Disease requiring IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab) every 14 days
* No prior chemotherapy for this adenocarcinoma with the exception of adjuvant chemotherapy
* Signed and dated informed consent document.

Exclusion Criteria

* Medical history of cancer within 5 years
* Medical contraindication for a treatment consisted of IV chemotherapy (5 Fluorouracil +/- oxaliplatin +/- irinotecan) +/- targeted therapy (cetuximab or panitumumab or bevacizumab)
* Patient with known psychiatric or substance abuse disorders that could interfere with cooperation with the requirements of the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice GANGLOFF, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2015/076/HP

Identifier Type: -

Identifier Source: org_study_id

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