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

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ClinicalTrials.gov Identifier: NCT02872779
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Circulating Markers Metastatic Colorectal Cancer Procedure: Blood sampling for free mutant DNA analysis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients Treated for Metastatic Colorectal cancer
Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer
Procedure: Blood sampling for free mutant DNA analysis
Blood sampling for Patients Treated for Metastatic Colorectal cancer




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872779


Contacts
Contact: Alice GANGLOFF, MD alice.gangloff@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
France
Rouen University Hospital Recruiting
Rouen, France
Sub-Investigator: Pierre MICHEL, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Alice GANGLOFF, MD Rouen University Hospital

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02872779     History of Changes
Other Study ID Numbers: 2015/076/HP
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases