← Back to Clinical Trials
Recruiting Phase 3 NCT05861505

COLLISION RELAPSE Trial

Trial Parameters

Condition Colorectal Cancer
Sponsor Amsterdam UMC, location VUmc
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 360
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-24
Completion 2027-05-01
Interventions
Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)Repeat local treatment

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, psychol

Related Trials