Clinical trial NCT02872779: Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
Official title: Correlation Between Circulating Tumour Markers Early Variations and Clinical Response in First Line Treatment of Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circulating Markers
Metastatic Colorectal Cancer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Difference from baseline in the number of free mutant DNA in blood
timeFrame: 5 weeks
Secondary outcomes:
measure: Difference from baseline in the number of free mutant DNA in blood
timeFrame: 3 weeks
measure: Evaluation of response based on the RECIST 1.1 guideline
timeFrame: 3 Months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Alice GANGLOFF, MD
role: PRINCIPAL_INVESTIGATOR
References: