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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

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