Comparing thermal ablation and surgical resection for liver metastases from colorectal cancer

A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases

This study is testing whether thermal ablation or surgical removal works better for people with liver tumors caused by colorectal cancer in terms of preventing the tumors from coming back.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Oslo University Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Oslo)
• Trial ID: NCT05129787 on ClinicalTrials.gov

What this trial studies

This clinical trial involves 230 patients with colorectal cancer liver metastases who will be randomly assigned to receive either thermal ablation or surgical resection. The primary objective is to compare the rates of local tumor progression within 12 months between the two treatment methods. Additionally, the study aims to evaluate health-related quality of life, perform a cost-effectiveness analysis, and assess disease-free and overall survival rates. The trial is designed as a randomized, controlled, multicenter, double-blinded non-inferiority trial to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically verified colorectal cancer and liver metastases eligible for either resection or ablation.

Not a fit: Patients with unresectable lung metastases or extrahepatic metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence to guide treatment decisions between thermal ablation and surgical resection for patients with colorectal cancer liver metastases.

How similar studies have performed: While there is increasing use of thermal ablation, this study aims to provide high-level evidence in a randomized controlled setting, addressing gaps in previous research.

Eligibility criteria

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.

Where this trial is running

Oslo

• Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital — Oslo, Norway (RECRUITING)

Study contacts

• Study coordinator: Åsmund A Fretland, MD PhD

Conditions: Colorectal Cancer Metastatic