COLLISION RELAPSE Trial

• Status: Recruiting
• Trial end date: 2028-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amsterdam UMC, location VUmc

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