A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients

Launched by JULES BORDET INSTITUTE · Aug 2, 2022

Keywords

ClinConnect Summary

The COPERNIC trial is looking at how changes in circulating tumor DNA (ctDNA) can help us understand the effectiveness of treatment in patients with advanced colorectal cancer who have not responded to standard chemotherapy. Participants in this study will receive standard chemotherapy chosen by their doctor and will have regular scans to check their tumor's response to treatment. Alongside this, blood samples will be collected at specific times to analyze ctDNA, which may provide insights into how well the treatment is working.

To be eligible for this trial, participants must be at least 18 years old, have confirmed colorectal cancer that cannot be surgically removed, and have already received two prior treatments for their cancer. They should also have measurable disease on their scans and a life expectancy of at least three months. Throughout the study, patients can expect regular check-ups, blood tests, and imaging to monitor their progress. Importantly, the trial aims to gather both prospective and retrospective data to better understand how ctDNA levels correlate with treatment outcomes, which could lead to improved future therapies for colorectal cancer.

Gender

ALL

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.