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Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study (COPE)

Primary Purpose

Colorectal Cancer, Non Small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Liquid biopsy

About this trial

This is an interventional other trial for Colorectal Cancer focused on measuring advanced, metastatic, liquid biopsy, genetic profiling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years,
Histology: colorectal cancer, non-small cell lung cancer,
Locally advanced/unresectable and/or metastatic solid tumor,
Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Appendix 1),
Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally > 10 mm,
No previous systemic treatment for advanced disease,
Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,
Eligible to first-line systemic therapy,
Patient with a social security in compliance with the French law,
Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

Radiological evidence of symptomatic or progressive brain metastases,
Abnormal coagulation contraindicating biopsy,
Inability to swallow,
Major problem with intestinal absorption,
Previous allogeneic bone marrow transplant,
Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
Individuals deprived of liberty or placed under guardianship,
Pregnant or breast feeding women,
Previous enrolment in the present study,
Any contraindication to first-line systemic therapy.

Sites / Locations

Centre hospitalier de la Côte BasqueRecruiting
Clinique Tivoli-DucosRecruiting
Institut BergonieRecruiting
Polyclinique Bordeaux Nord AquitaineRecruiting
CHRU BrestRecruiting
Polyclinique MarzetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Experimental procedure for colorectal cancer

Standard procedure for colorectal cancer

Experimental procedure for non-small cell lung cancer

Standard procedure for non-small cell lung cancer

Arm Description

Patients with Advanced colorectal cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment)

Patients with Advanced colorectal cancer will be managedby initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment)

Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Outcomes

Primary Outcome Measures

Assessment of cancer outcome in terms of overall survival (2 distincts population)

Overall Survival (OS) is defined as the time interval between the date of randomization and the date of death (of any cause).

Secondary Outcome Measures

Proportion of patients with at least one actionable alteration (in 2 distincts populations)

An actionable alteration is determined according to the molecular tumor board.

Proportion of patients treated with a targeted therapy (in 2 distincts populations)

A profiling-based targeted therapy corresponds to a therapy targeting an actionable alteration

Full Information

NCT ID

NCT04258137

First Posted

February 4, 2020

Last Updated

March 1, 2023

Sponsor

Institut Bergonié

1. Study Identification

Unique Protocol Identification Number

NCT04258137

Brief Title

Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study

Acronym

COPE

Official Title

Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 4, 2020 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Bergonié

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients. For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B: Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis) Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).

Detailed Description

Primary tumor tissue, if accessible at all, does not always provide enough information to stratify individual patients to the most promising therapy. Re-analysis of metastatic lesions by needle biopsy is possible but invasive, and limited by the known intra-patient heterogeneity of individual lesions. These hurdles might be overcome by analyzing circulating tumor DNA (liquid biopsy), which in principle might reflect all subclones present at that specific time point and allow sequential monitoring of disease evolution. Once tumor's genetic profiling is available, patients will be discussed within a multidisciplinary tumor board (MTB) which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient. This MTB involves clinical oncologists, molecular biologists and clinical or biological project manager. All the patients carrying an actionnable alteration will be proposed to receive a matched drug or to enter in a matched clinical trial depending on the possibility of inclusion at the time of molecular report. the investigators hypothesize that implementing sequential circulating tumor DNA analysis can improve management of patients with advanced cancer and therefore their survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Non Small Cell Lung Cancer

Keywords

advanced, metastatic, liquid biopsy, genetic profiling

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

For each distinct population of patients with Advanced solid tumor (colorectal cancer and non-small-cell lung cancer), patients will be randomized between two arms: Experimental procedure: initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment). Standard procedure: initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental procedure for colorectal cancer

Arm Type

Experimental

Arm Description

Arm Title

Standard procedure for colorectal cancer

Arm Type

No Intervention

Arm Description

Patients with Advanced colorectal cancer will be managedby initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Arm Title

Experimental procedure for non-small cell lung cancer

Arm Type

Experimental

Arm Description

Arm Title

Standard procedure for non-small cell lung cancer

Arm Type

No Intervention

Arm Description

Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Intervention Type

Genetic

Intervention Name(s)

Liquid biopsy

Intervention Description

Liquid biopsy will be performed at cycle 1 day 1 and cycle 2 day of each line of systemic treatment, at each tumor evaluation by Imaging and at confirmation of progression

Primary Outcome Measure Information:

Title

Assessment of cancer outcome in terms of overall survival (2 distincts population)

Description

Overall Survival (OS) is defined as the time interval between the date of randomization and the date of death (of any cause).

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Proportion of patients with at least one actionable alteration (in 2 distincts populations)

Description

An actionable alteration is determined according to the molecular tumor board.

Time Frame

Throughout the study: an average of 18 months

Title

Proportion of patients treated with a targeted therapy (in 2 distincts populations)

Description

A profiling-based targeted therapy corresponds to a therapy targeting an actionable alteration

Time Frame

Throughout the study: an average of 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years, Histology: colorectal cancer, non-small cell lung cancer, Locally advanced/unresectable and/or metastatic solid tumor, Eastern Cooperative Oncology Group (ECOG) performance status < 2 (Appendix 1), Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally > 10 mm, No previous systemic treatment for advanced disease, Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose, Eligible to first-line systemic therapy, Patient with a social security in compliance with the French law, Voluntary signed and dated written informed consent prior to any study specific procedure. Exclusion Criteria: Inability to swallow, Major problem with intestinal absorption, Previous allogeneic bone marrow transplant, Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer, Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV), Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol, Individuals deprived of liberty or placed under guardianship, Pregnant or breast feeding women, Previous enrolment in the present study, Any contraindication to first-line systemic therapy.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Antoine ITALIANO, MD, PhD

Phone

5.56.33.33.33

Ext

+33

a.italiano@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Simone MATHOULIN-PELISSIER, MD, PhD

s.mathoulin@bordeaux.unicancer.fr

Facility Information:

Facility Name

Centre hospitalier de la Côte Basque

City

Bayonne

ZIP/Postal Code

64109

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thomas GRELLETY, MD

tgrellety@ch-cotebasque.fr

Facility Name

Clinique Tivoli-Ducos

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Valérie COCHIN, MD

v.cochin@tivoli-oncologie.fr

Facility Name

Institut Bergonie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antoine ITALIANO, MD, PhD

a.italiano@bordeaux.unicancer.fr

First Name & Middle Initial & Last Name & Degree

Antoine ITALIANO, MD, PhD

Facility Name

Polyclinique Bordeaux Nord Aquitaine

City

Bordeaux

ZIP/Postal Code

33077

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cédric LECAILLE, MD

lecail@hotmail.fr

Facility Name

CHRU Brest

City

Brest

ZIP/Postal Code

29200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Philippe METGES, MD,PhD

jean-philippe.metges@chu-brest.fr

Facility Name

Polyclinique Marzet

City

Pau

ZIP/Postal Code

64000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvestre LE MOULEC, MD

sylvestre.lemoulec@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study

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