Ablation vs Resection of Colorectal Cancer Liver Metastases

NCT ID: NCT05129787

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-16
• Study Completion Date: 2025-12-31

Brief Summary

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

Detailed 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.

Conditions

Colorectal Cancer Metastatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Surgical resection

Liver resection

Group Type: ACTIVE_COMPARATOR

Surgical resection

Intervention Type: PROCEDURE

Resection of metastasis

Thermal ablation

Thermal ablation (Microwave or radiofrequency)

Group Type: EXPERIMENTAL

Thermal ablation

Intervention Type: PROCEDURE

Ablation of metastasis

Interventions

Surgical resection

Resection of metastasis

Intervention Type: PROCEDURE

Thermal ablation

Ablation of metastasis

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Åsmund Avdem Fretland

Consultant HPB surgeon, MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bjørn Edwin, Professor

Role: STUDY_DIRECTOR

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

Locations

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

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Åsmund A Fretland, MD PhD

Role: CONTACT

Phone: 004723070100

Email: aasmund@fretland.no

Bjørn Edwin, Professor

Role: CONTACT

Phone: 004793008635

Email: bjoedw@ous-hf.no

Facility Contacts

Marianne Moe, Head nurse

Role: primary

References

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. doi: 10.1245/s10434-025-17984-5. Online ahead of print.

Reference Type: DERIVED

PMID: 40858956 (View on PubMed)

Other Identifiers

REK255384

Identifier Type: -

Identifier Source: org_study_id