| NCT ID | NCT05861505 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2023-04-24 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 360 participants in total. It began in 2023-04-24 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective is to demonstrate superiority of neoadjuvant systemic therapy followed by repeat local treatment as compared to upfront repeat local treatment in patients with at least one locally treatable recurrent CRLM in the absence of extrahepatic disease.
Eligibility Criteria
Inclusion criteria * Age \>18 years * Good performance status (ECOG 0-2 // ASA 1-3) * Histological documentation of primary colorectal tumor * Local treatment performed for initial CRLM * New recurrence ≤12 months * ≥1 locally treatable CRLM (resectable\* and/or ablatable) * Total number of new CRLM ≤5 * Chemo-naïve or history of response to CAPOX/FOLFOX/FOLRIRI * Life expectancy of at least 12 weeks * Adequate bone marrow, liver and renal function * Written informed consent Exclusion criteria * Extrahepatic disease * MSI/dMMR * Radical local treatment unfeasible or unsafe (e.g. insufficient future liver volume) * Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites) * Uncontrolled infections (\> grade 2 NCI-CTC version 3.0) * Pregnant or breast-feeding subjects * Immuno- or chemotherapy ≤ 6 weeks prior to the randomization * Severe allergy to contrast media not controlled with premedication * Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results ECOG = Eastern Cooperative Oncology Group, ASA = American Society of Anesthesiologists, MSI = Microsatellite instability, dMMR = deficient mismatch repair \* Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate liver reserve
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05861505 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05861505 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 360 participants.
Is NCT05861505 currently recruiting?
Yes, NCT05861505 is actively recruiting participants. Contact the research team at interventieradiologie@vumc.nl for enrollment information.
Where is the NCT05861505 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05861505 clinical trial?
NCT05861505 is sponsored by Amsterdam UMC, location VUmc. The trial plans to enroll 360 participants.
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