Trial Title:
A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients
NCT ID:
NCT05487248
Condition:
Unresectable Locally Advanced Colorectal Cancer
Metastatic Colorectal Cancer
Candidate for Third-line or Subsequent Lines of Therapy
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
colorectal cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood Sample Collection
Description:
For subjects receiving treatments with a 2- or 4-weekly schedule, blood samples for ctDNA
testing will be collected at the following timepoints:
- Before treatment start (day 1)
- 2 weeks after treatment start (day 15)
- 4 weeks after treatment start (day 29)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the
same time of each imaging tumour assessment)
For subjects receiving treatments with a 3-weekly schedule, blood samples for ctDNA
testing will be collected at the following timepoints:
- Before treatment start (day 1)
- 3 weeks after treatment start (day 22)
- 6 weeks after treatment start (day 43)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the
same time of each imaging tumour assessment)
Arm group label:
Unresectable locally advanced or metastatic colorectal cancer patients
Summary:
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC
subjects who meet all eligibility criteria will be treated with standard systemic
chemotherapy (the decision about the treatment regimen being made by the treating
physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan)
at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to
treatment will be assessed by the local investigators according to the RECIST criteria
version 1.1. Blinded, independent central review of the imaging scan will be carried out,
this having no impact on treatment decisions thatwhich will remain the prerogative of the
treating physician.
Serial blood samples from study subjects will be collected at pre-defined time points for
ctDNA testing. Also, archived tumour tissue from each subject will be collected.
Prospective and retrospective ctDNA analyses on blood samples will be carried out, and
dynamics of ctDNA will be correlated with treatment outcomes prognosis.
Detailed description:
COPERNIC is an international, multicentre, single-arm study. Chemo-refractory mCRC
subjects who meet all eligibility criteria will be treated with standard systemic
chemotherapy (the decision about the treatment regimen being made by the treating
physician) and undergo tumour assessment by standard imaging (either CT scan or MRI scan)
at baseline and every 8 or 12 weeks until evidence of tumour progression. Response to
treatment will be assessed by the local investigators according to the RECIST criteria
version 1.1. Blinded, independent central review of the imaging scan will be carried out,
this having no impact on treatment decisions which will remain the prerogative of the
treating physician.
Serial blood samples from study subjects will be collected at pre-defined time points for
ctDNA testing. Also, archived tumour tissue from each subject will be collected.
Prospective and retrospective ctDNA analyses on blood samples will be carried out, and
dynamics of ctDNA will be correlated with prognosis.
Two ctDNA assays will be used in this study:
- FoundationOne Liquid CDx (F1LCDx) for comprehensive genomic profile (CGP) assessment
- FoundationOne®Tracker for monitoring purpose
Time points for blood samples collection:
For subjects receiving treatments with a 2- or 4-weekly schedule, blood samples for ctDNA
testing will be collected at the following timepoints:
- Before treatment start (day 1)
- 2 weeks after treatment start (day 15)
- 4 weeks after treatment start (day 29)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the
same time of each imaging tumour assessment)
For subjects receiving treatments with a 3-weekly schedule, blood samples for ctDNA
testing will be collected at the following timepoints:
- Before treatment start (day 1)
- 3 weeks after treatment start (day 22)
- 6 weeks after treatment start (day 43)
- 8 or 12 weeks after treatment start and every 8 or 12 weeks thereafter (i.e., at the
same time of each imaging tumour assessment)
ctDNA analyses will be done in a centralised laboratory (Foundation Medicine Inc). Full
report of the ctDNA analysis will be provided to the study team to allow correlation with
clinical data and exploratory analyses. The results of the ctDNA analysis will not be
communicated to the treating physician (with the only exception of the analysis by F1CDx
on tumour tissue at screening) and therefore will not have any impact on treatment
decision (i.e., all study subjects will be treated according to standard practice).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years old
2. Male or female
3. ECOG performance status ≤2
4. Must have histologically or cytologically verified colorectal cancer adenocarcinoma
5. Inoperable locally advanced or metastatic disease
6. Presence of measurable disease (by RECIST criteria version 1.1) on baseline CT scan
of the thorax/abdomen/pelvis or CT scan of the thorax and MRI of the abdomen/pelvis
7. At least two prior systemic treatments for advanced/metastatic colorectal cancer
including oxaliplatin and irinotecan-based therapy (adjuvant or neoadjuvant systemic
chemotherapy will be considered if tumour progression was documented within 6 month
of the last chemotherapy dose)
8. Candidate for standard third-line or subsequent lines of therapy as per decision of
the treating physician
9. Life expectancy of at least 3 months
10. Women of childbearing potential must have a negative serum pregnancy test done
within 28 days prior to enrolment.
11. Effective contraception is in place for women of childbearing potential.
12. Completion of all necessary screening procedures within 28 days prior to enrolment.
13. Availability of archived tumour tissue
14. Signed Informed Consent form (ICF) obtained prior to any study related procedure.
Inclusion criterion applicable to FRANCE only
15. Affiliated to the French Social Security System
Exclusion Criteria:
1. Tumours other than colorectal cancer
2. Histologies other than adenocarcinoma
3. Any baseline medical condition that would contraindicate the use of systemic
chemotherapy or may preclude the regular administration of the same
4. Any psychiatric condition that would prohibit the understanding or rendering of
informed consent
5. Other invasive malignancy within 3 years except for non-invasive malignancies such
as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal
carcinoma in situ of the breast that has/have been surgically cured
6. Subject with a significant medical, neuro-psychiatric, or surgical condition,
currently uncontrolled by treatment, which, in the principal investigator's opinion,
may interfere with completion of the study.
7. Pregnant and/ or lactating women
Exclusion criterion applicable to FRANCE only
8. Vulnerable persons according to the article L.1121-6 of the Public Health Code,
adults who are the subject of a measure of legal protection or unable to express
their consent according to article L.1121-8 of the Public Health Code.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut Jules Bordet
Address:
City:
Anderlecht
Zip:
1070
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Rita Saude Conde, MD
Phone:
+32 (0)2 541 3196
Email:
rita.saudeconde@hubruxelles.be
Investigator:
Last name:
Alain Hendlisz, MD
Email:
Principal Investigator
Facility:
Name:
UZ Antwerpen
Address:
City:
Antwerpen
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Silke Raats
Phone:
0032 3 821 42 15
Email:
Silke.Raats@uza.be
Investigator:
Last name:
Timon Vandamme, MD
Email:
Principal Investigator
Facility:
Name:
CHIREC Delta
Address:
City:
Brussels
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Anne Makamte
Phone:
+32 2 434 54 21
Email:
Anne.Makamte@chirec.be
Investigator:
Last name:
Francesco Puleo, MD
Email:
Principal Investigator
Facility:
Name:
CHU Ambroise Pare
Address:
City:
Mons
Zip:
7000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Nadia Santoro
Phone:
+32(0) 65 41 75 14
Email:
nadia.santoro@helora.be
Investigator:
Last name:
Marie Diaz, MD
Email:
Principal Investigator
Facility:
Name:
Cliniques Universitaires Saint Luc
Address:
City:
Woluwe-Saint-Lambert
Zip:
1200
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Marie-Laure Castella
Phone:
+ 32 2 764 54 27
Email:
marie-laure.castella@saintluc.uclouvain.be
Investigator:
Last name:
Marc Van den Eynde, MD
Email:
Principal Investigator
Facility:
Name:
Centre Georges François Leclerc
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
François Ghiringhelli, MD
Phone:
03 80 73 77 56
Email:
FGhiringhelli@cgfl.fr
Contact backup:
Last name:
Lise Faglin
Facility:
Name:
Hopital Franco-Britannique - Fondation Cognacq-Jay
Address:
City:
Levallois-Perret
Zip:
92300
Country:
France
Status:
Recruiting
Contact:
Last name:
Benoist Chibaudel
Phone:
+33(0)147595965
Email:
benoist.chibaudel@cognacq-jay.fr
Facility:
Name:
Hopital privé Jean Mermoz
Address:
City:
Lyon
Country:
France
Status:
Recruiting
Contact:
Last name:
Pascal Artru, MD
Phone:
+33437538726
Email:
dr.artru@wanadoo.fr
Facility:
Name:
Hopital St-Louis
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Thomas Aparicio, MD
Phone:
01 42 49 95 71
Email:
thomas.aparicio@aphp.fr
Contact backup:
Last name:
Ewa Bartnicka
Facility:
Name:
CHU Poitiers
Address:
City:
Poitiers
Country:
France
Status:
Recruiting
Contact:
Last name:
Camille Evrard
Phone:
0549444279
Email:
camille.evrard@chu-poitiers.fr
Facility:
Name:
ICO
Address:
City:
Saint-Herblain
Country:
France
Status:
Recruiting
Contact:
Last name:
Judith Raimbourg
Phone:
0240679705
Email:
judith.raimbourg@ico.unicancer.fr
Facility:
Name:
ICANS Strasbourg
Address:
City:
Strasbourg
Country:
France
Status:
Recruiting
Contact:
Last name:
Meher Ben Abdelghani
Phone:
+33 (0)3 68 76 71 40
Email:
m.ben-abdelghani@icans.eu
Start date:
October 12, 2023
Completion date:
July 12, 2026
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Collaborator:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487248