Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer (COCA-MACS)

University Hospital, Rouen

Status

Completed

Conditions

Metastatic Colorectal Cancer

Circulating Markers

Treatments

Procedure: Blood sampling for free mutant DNA analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT02872779

2015/076/HP

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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