Monitoring ctDNA Changes in Patients with Advanced Colorectal Cancer
A Study of On-treatment ctDNA Changes in Chemo-refractory Colorectal Cancer Patients
This study is testing if tracking changes in blood samples can help doctors understand how well standard chemotherapy works for patients with advanced colorectal cancer that hasn't responded to other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 103 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jules Bordet Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 12 sites (Anderlecht and 11 other locations) |
| Trial ID | NCT05487248 on ClinicalTrials.gov |
What this trial studies
This international, multicentre study focuses on patients with chemo-refractory metastatic colorectal cancer (mCRC) who will receive standard systemic chemotherapy as determined by their treating physician. Participants will undergo tumor assessments using imaging techniques like CT or MRI scans at baseline and periodically until tumor progression is observed. Blood samples will be collected at specific intervals for circulating tumor DNA (ctDNA) analysis, which will be correlated with treatment response and prognosis. The study aims to utilize ctDNA assays to provide insights into the effectiveness of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed, inoperable locally advanced or metastatic colorectal cancer who have undergone at least two prior systemic treatments.
Not a fit: Patients who have not received prior systemic treatments or those with operable disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment responses in colorectal cancer, potentially leading to more personalized and effective therapies.
How similar studies have performed: Other studies utilizing ctDNA monitoring in cancer treatment have shown promising results, indicating that this approach is gaining traction in the field.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Anderlecht and 11 other locations
- Institut Jules Bordet — Anderlecht, Belgium (Recruiting)
- UZ Antwerpen — Antwerpen, Belgium (Recruiting)
- CHIREC Delta — Brussels, Belgium (Recruiting)
- CHU Ambroise Pare — Mons, Belgium (Recruiting)
- Cliniques Universitaires Saint Luc — Woluwe-Saint-Lambert, Belgium (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Active_not_recruiting)
- Hopital Franco-Britannique - Fondation Cognacq-Jay — Levallois-Perret, France (Active_not_recruiting)
- Hopital privé Jean Mermoz — Lyon, France (Active_not_recruiting)
- Hopital St-Louis — Paris, France (Active_not_recruiting)
- CHU Poitiers — Poitiers, France (Active_not_recruiting)
- ICO Saint-Herblain — Saint-Herblain, France (Active_not_recruiting)
- ICANS Strasbourg — Strasbourg, France (Active_not_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.