Ablation vs Resection of Colorectal Cancer Liver Metastases

NCT05129787 | Active Not Recruiting DMC

• 1 other identifier: REK255384
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Local tumor progression

  Local tumor progression at site of treatment

  12 months

Secondary Outcomes (10)

• Overall survival

  60 months

• Overall survival (secondary analysis)

  60 months

• Disease free survival

  60 months

• Postoperative complications

  30 days

• Health related quality of life

  12 months

Study Arms (2)

Surgical resection

ACTIVE COMPARATOR

Liver resection

Procedure: Surgical resection

Thermal ablation

EXPERIMENTAL

Thermal ablation (Microwave or radiofrequency)

Procedure: Thermal ablation

Interventions

Surgical resection PROCEDURE

Resection of metastasis

Surgical resection

Thermal ablation PROCEDURE

Ablation of metastasis

Thermal ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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
• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• Hansen 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 Aug 26;32(12):9146-53. doi: 10.1245/s10434-025-17984-5. Online ahead of print.

  PMID: 40858956 DERIVED

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bjørn Edwin, Professor

  Head of clinical research, The Intervention Centre, Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking will be performed by large drapings on wounds and masking of operation notes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant HPB surgeon, MD PhD

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 22, 2021
• Study Start: December 16, 2021
• Primary Completion (Estimated): October 23, 2026
• Study Completion (Estimated): October 23, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3-5 years
• Access Criteria: Upon contact to PI

Locations

NO (1)