Ablation vs Resection of Colorectal Cancer Liver Metastases

Colorectal Cancer Metastatic Clinical Trial

— NEW-COMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05129787
• Other study ID #: REK255384
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2021
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Oslo University Hospital
• Contact: Åsmund A Fretland, MD PhD
• Phone: 004723070100
• Email: aasmund[@]fretland.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Procedure:
• Surgical resection
Resection of metastasis
• Thermal ablation
Ablation of metastasis

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor progression	Local tumor progression at site of treatment	12 months
Secondary	Overall survival	Overall survival following treatment	60 months
Secondary	Overall survival (secondary analysis)	A secondary analysis will be performed on a oncologically more homogenous group of patients that fulfil the following requirements: a) no previous surgical procedure on the liver, b) no extrahepatic metastases, and c) that had their primary tumor resected	60 months
Secondary	Disease free survival	DFS	60 months
Secondary	Postoperative complications	Morbidity	30 days
Secondary	Health related quality of life	HRQoL is measured using SF-36	12 months
Secondary	Cost-Effectiveness	An analysis of cost will be performed to assess cost-effectiveness	12 months
Secondary	Hemodynamic response	The hemodynamic response to the two interventions will be recorded and compared	7 days
Secondary	Ventilation methods	The intraoperative movement of the liver will be measured using different ventilation methods (one lung ventilation, jet ventilation, gentle double lung ventilation). The movement of the liver during the different ventilation methods will be assessed in cm.	1 day
Secondary	Cerebral flow	Intraoperative cerebral blood flow will be measured and related to cardiac output and other hemodynamic measures. Micro bubbles caused by the treatment will be visualized using ultrasonography.	1 day
Secondary	Inflammatory response	The inflammatory response (cytokines, complement, catecholamines) will be compared.	7 days