Clinical trial · Interventional
COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation
COLLISION XL: Unresectable Colorectal Liver Metastases: Stereotactic Body Radiotherapy vs. Microwave Ablation - a Phase II Prospective Randomized Controlled Trial for Intermediate-size (3 - 5 cm) Colorectal Liver Metastases
- 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)
Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasing lesion size. Guidelines state that thermal ablation is the preferred option for unresectable CRLM ≤3cm and stereotactic body radiotherapy (SBRT) when thermal ablation is not possible. It remains uncertain what local treatment method should be recommended for unresectable CRLM of 3-5cm.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Liver Metastasis Colon Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation | Device | — | UNRESOLVED |
| Stereotactic Body Radiotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Stereotactic Body Radiotherapy
- description
- Patients included will undergo Stereotactic Body Radiotherapy (SBRT) of hepatic metastases.
- interventionNames
- Device: Stereotactic Body Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Microwave Ablation
- description
- Patients included will undergo Microwave Ablation (MWA) of hepatic metastases.
- interventionNames
- Device: Microwave Ablation
Primary outcomes (1)
- measure
- One-year local tumor progression-free survival
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions); * Additional CRLM are allowed if considered either resectable or ablatable and \<3cm * No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis); * For subjects with liver only disease the maximum number of CRLM is 10; for subjects with limited extrahepatic disease the maximum number of CRLM is 5; * Prior focal liver treatment is allowed * Subjects without prior focal liver treatment should be either unsuitable for 1st line chemotherapy or have progressed under/after 1st-line chemotherapy; * Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment should be unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable). Exclusion Criteria: * Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites); * Pregnant or breast-feeding subjects; * Immunotherapy ≤ 6 weeks prior to the procedure; * Chemotherapy ≤ 6 weeks prior to the procedure; * Severe allergy to contrast media not controlled with premedication.
References
Publications (1)
- DERIVEDvan der Lei S, Dijkstra M, Nieuwenhuizen S, Schulz HH, Vos DJW, Versteeg KS, Buffart TE, Swijnenburg RJ, de Vries JJJ, Bruynzeel AME, van den Tol MP, Scheffer HJ, Puijk RS, Haasbeek CJA, Meijerink MR; and COLLISION Trial Group. Unresectable Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Aug;46(8):1076-1085. doi: 10.1007/s00270-023-03498-8. Epub 2023 Jul 10. PMID 37430016