## Protocol Section
### Identification Module
**NCT ID:** NCT02872779

**Acronym:** COCA-MACS

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 2015/076/HP
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Rouen
### Status Module
#### Completion Date
**Date:** 2020-08

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-08-22

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-21

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-08

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2016-08-19
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-16
**Study First Submit QC Date:** 2016-08-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Rouen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Circulating Markers

- Metastatic Colorectal Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 74

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Blood sampling for free mutant DNA analysis for Patients Treated for Metastatic Colorectal cancer

**Intervention Names:**

- Procedure: Blood sampling for free mutant DNA analysis

**Label:** Patients Treated for Metastatic Colorectal cancer

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Patients Treated for Metastatic Colorectal cancer

**Description:** Blood sampling for Patients Treated for Metastatic Colorectal cancer

**Name:** Blood sampling for free mutant DNA analysis

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Difference from baseline in the number of free mutant DNA in blood

**Time Frame:** 5 weeks

#### Secondary Outcomes

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

**Measure:** Difference from baseline in the number of free mutant DNA in blood

**Time Frame:** 3 weeks

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

**Measure:** Evaluation of response based on the RECIST 1.1 guideline

**Time Frame:** 3 Months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** alice.gangloff@chu-rouen.fr

**Name:** Alice GANGLOFF, MD

**Role:** CONTACT

**Contact 2:**

**Email:** julien.blot@chu-rouen.fr

**Name:** Julien BLOT

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rouen

**Contacts:**

***Contact 1:***

- **Name:** Pierre MICHEL, Pr

- **Role:** SUB_INVESTIGATOR

**Country:** France

**Facility:** Rouen University Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Rouen University Hospital

**Name:** Alice GANGLOFF, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
