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

Metastatic Colorectal Cancer Clinical Trial

— COCA-MACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02872779
• Other study ID #: 2015/076/HP
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 21, 2017
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: Alice GANGLOFF, MD
• Email: alice.gangloff[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circulating Markers
• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference from baseline in the number of free mutant DNA in blood	Variation of free mutant DNA kinetic at week 5 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)	5 weeks
Secondary	Difference from baseline in the number of free mutant DNA in blood	Variation of free mutant DNA kinetic at week 3 to predict tumor progression at 3 months (Evaluation based on the RECIST 1.1 guideline)	3 weeks
Secondary	Evaluation of response based on the RECIST 1.1 guideline	sensitivity and specificity of free mutant DNA kinetic at Week 5 (RECIST) to predict tumor progression at 3 months (RECIST)	3 Months