Ablation vs Resection of Colorectal Cancer Liver Metastases (NEW-COMET)
Primary Purpose
Colorectal Cancer Metastatic
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Surgical resection
Thermal ablation
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer Metastatic
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.
Sites / Locations
- Oslo University Hospital, Department of Gastrointestinal surgery, The National HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Surgical resection
Thermal ablation
Arm Description
Liver resection
Thermal ablation (Microwave or radiofrequency)
Outcomes
Primary Outcome Measures
Local tumor progression
Local tumor progression at site of treatment
Secondary Outcome Measures
Overall survival
Overall survival following treatment
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
Disease free survival
DFS
Postoperative complications
Morbidity
Health related quality of life
HRQoL is measured using SF-36
Cost-Effectiveness
An analysis of cost will be performed to assess cost-effectiveness
Full Information
NCT ID
NCT05129787
First Posted
November 2, 2021
Last Updated
December 17, 2021
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05129787
Brief Title
Ablation vs Resection of Colorectal Cancer Liver Metastases
Acronym
NEW-COMET
Official Title
A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Masking will be performed by large drapings on wounds and masking of operation notes
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Surgical resection
Arm Type
Active Comparator
Arm Description
Liver resection
Arm Title
Thermal ablation
Arm Type
Experimental
Arm Description
Thermal ablation (Microwave or radiofrequency)
Intervention Type
Procedure
Intervention Name(s)
Surgical resection
Intervention Description
Resection of metastasis
Intervention Type
Procedure
Intervention Name(s)
Thermal ablation
Intervention Description
Ablation of metastasis
Primary Outcome Measure Information:
Title
Local tumor progression
Description
Local tumor progression at site of treatment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Overall survival following treatment
Time Frame
60 months
Title
Overall survival (secondary analysis)
Description
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
Time Frame
60 months
Title
Disease free survival
Description
DFS
Time Frame
60 months
Title
Postoperative complications
Description
Morbidity
Time Frame
30 days
Title
Health related quality of life
Description
HRQoL is measured using SF-36
Time Frame
12 months
Title
Cost-Effectiveness
Description
An analysis of cost will be performed to assess cost-effectiveness
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Åsmund A Fretland, MD PhD
Phone
004723070100
Email
aasmund@fretland.no
First Name & Middle Initial & Last Name or Official Title & Degree
Bjørn Edwin, Professor
Phone
004793008635
Email
bjoedw@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Edwin, Professor
Organizational Affiliation
Head of clinical research, The Intervention Centre, Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Moe, Head nurse
Phone
+4723072529
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD maybe shared pending approval from local data protection officer
IPD Sharing Time Frame
3-5 years
IPD Sharing Access Criteria
Upon contact to PI
Learn more about this trial
Ablation vs Resection of Colorectal Cancer Liver Metastases
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