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Completed

NCT Number: NCT02872779

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

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.

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Key information

Conditions

Circulating Markers Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastatic Colorectal Cancer Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling for free mutant DNA analysis

Procedure

Blood sampling for Patients Treated for Metastatic Colorectal cancer

Primary outcomes

  1. Difference from baseline in the number of free mutant DNA in blood

    Time frame: 5 weeks

    Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)

Secondary outcomes

  1. Difference from baseline in the number of free mutant DNA in blood

    Time frame: 3 weeks

    Variation of free mutant DNA kinetic at week 3 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)

  2. Evaluation of response based on the RECIST 1.1 guideline

    Time frame: 3 Months

    sensitivity and specificity of free mutant DNA kinetic at Week 5 (RECIST) to predict tumor progression at 3 months (RECIST)

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: COCA-MACS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2016
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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