Ablation vs Resection of Colorectal Cancer Liver Metastases — NEW-COMET  

Colorectal Cancer Metastatic Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

Rationale: The use of thermal ablation of liver tumors is rapidly increasing. This is despite a lack of high-level evidence of the oncologic efficacy of ablation. Ablation is most often used in cases where resection is not possible, but as the technique has improved it is increasingly used as a substitute for resection. A majority of studies on ablation are hampered by selection bias. Selection bias can only be overcome in a randomized controlled trial.

Primary objective:

To compare rates of local tumor progression within 12 months in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.

Secondary objectives:

• To establish a pipeline for immediate three-dimensional verification of the ablated zone following thermal ablation of liver metastases.

• To compare health related quality of life in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.

• To perform a cost-effectiveness analysis (Cost per quality adjusted life year) of thermal ablation and resection of colorectal liver metastases.

• To compare disease-free and overall survival in in patients randomly assigned to thermal ablation or surgical resection of colorectal liver metastases.

• To evaluate the hemodynamic response to thermal ablation and laparoscopic resection of liver tumors.

Study design:

A randomized, controlled, multicenter, double-blinded non-inferiority trial.

Study population:

Two groups of 115 patients (230 in total) with colorectal liver metastasis eligible for radical treatment using EITHER resection OR ablation (not a combination).

Intervention:

Ablation of colorectal liver metastases

Control:

Resection of colorectal liver metastases

Main study parameters/endpoints:

The primary endpoint of the study is local recurrence of cancer at 12 months. Secondary endpoints include overall survival, disease free survival, health related quality of life, postoperative pain, complications, hospital stay and cost-effectiveness. ;

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

• NCT number: NCT05129787
• Study type: Interventional
• Source: Oslo University Hospital
• Contact: Åsmund A Fretland, MD PhD
• Phone: 004723070100
• Email: aasmund@fretland.no
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2021
• Completion date: December 2025