Clinical trial · Interventional
COLLISION RELAPSE Trial
COLLISION RELAPSE Trial - Recurrent Colorectal Liver Metastases: Repeat Local Treatment +/- Neoadjuvant Systemic Therapy - a Phase III Prospective Randomized Controlled Trial
NCT05861505CI-TRIAL-00066485recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | — | UNRESOLVED | — |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B) | Drug | — | UNRESOLVED |
| Repeat local treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Upfront repeat local treatment
- interventionNames
- Other: Repeat local treatment
- type
- EXPERIMENTAL
- label
- Neoadjuvant systemic therapy followed by repeat local treatment
- interventionNames
- Drug: Neoadjuvant systemic therapy (CAPOX+/-B FOLFOX+/-B FOLFIRI+/-B)
- Other: Repeat local treatment
Primary outcomes (1)
- measure
- Overall survival (OS) per patient
- timeFrame
- 5 years
- description
- Primary objective is to compare overall survival (OS) in both study arms, counting from the date of randomization to the date of death of the patient or to the last day of follow-up (censored).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDijkstra M, Kuiper BI, Schulz HH, van der Lei S, Puijk RS, Vos DJW, Timmer FEF, Scheffer HJ, Buffart TE, van den Tol MP, Lissenberg-Witte BI, Swijnenburg RJ, Versteeg KS, Meijerink MR; COLLISION Trial Group. Recurrent Colorectal Liver Metastases: Upfront Local Treatment versus Neoadjuvant Systemic Therapy Followed by Local Treatment (COLLISION RELAPSE): Study Protocol of a Phase III Prospective Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2024 Feb;47(2):253-262. doi: 10.1007/s00270-023-03602-y. Epub 2023 Nov 9. PMID 37943351