Clinical trial · Interventional
Ablation vs Resection of Colorectal Cancer Liver Metastases
A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases
NCT05129787CI-TRIAL-00103198NEW-COMETactive not recruitingN/AClinicalTrials.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)
230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgical resection | Procedure | — | UNRESOLVED |
| Thermal ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgical resection
- description
- Liver resection
- interventionNames
- Procedure: Surgical resection
- type
- EXPERIMENTAL
- label
- Thermal ablation
- description
- Thermal ablation (Microwave or radiofrequency)
- interventionNames
- Procedure: Thermal ablation
Primary outcomes (1)
- measure
- Local tumor progression
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified colorectal cancer * Colorectal liver metastases (proven or suspected) eligible for radical treatment using EITHER resection OR ablation (not a combination), as decided by the liver MDT meeting at the study center * The patient is fit to undergo both resection and ablation of all liver metastases * Size of largest lesion up to and including 30 mm * In case of solitary metastasis, resection plan includes resection of ≤ 2 anatomical segments. * In case of multiple metastases in one continuous resection, resection plan can include ≤ 4 anatomical segments (including hemihepatectomy) * ≤ 5 tumors to be treated in one procedure * Primary tumor either resected (primary first) or with a plan for curative treatment (liver first). Exclusion Criteria: • More than 3 lung metastases where 1 is \>10mm, or 1 lung metastasis \>15 mm (OR: unresectable lung metastases as decided by the lung MDT meeting) * Presence of extrahepatic, extrapulmonary metastases. * Surgical indication for removal of enlarged lymph nodes in the hepatic hilum. (Enlarged lymph nodes without indication of removal are not considered an exclusion criterium) * Tumor closer than 10 mm to right/left main bile duct * Suspected tumor infiltration to adjacent organs * Progression (as of RECIST \[18\]) on 2nd line chemotherapy * Previous inclusion in this trial * Not eligible for workup according to study criteria * Contraindication to contrast enhanced CT scan * Manifest liver cirrhosis * Pregnancy * ECOG performance status ≥3 * Simultaneous resection of primary tumor or any other concomitant surgical procedure * Any other reason why, in the investigator's opinion, the patient should not be included.
References
Publications (1)
- DERIVEDHansen IS, Lappen KR, Brudvik KW, Rosok BI, Bjork I, Ostergaard D, Andersen MH, Pelanis E, Espinoza AW, Halvorsen PS, Yaqub S, Lassen K, von Gohren Edwin B, Syversveen T, Fretland AA. A Randomized Controlled Trial of Resection Versus Thermal Ablation of Colorectal Cancer Liver Metastases (New Comet): Study Protocol. Ann Surg Oncol. 2025 Nov;32(12):9146-9153. doi: 10.1245/s10434-025-17984-5. Epub 2025 Aug 26. PMID 40858956