Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation (ISCOLIM)
Primary Purpose
Liver Metastasis Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
RFA (radiofrequency ablation)
Sponsored by
About this trial
This is an interventional treatment trial for Liver Metastasis Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with colorectal liver metastases planned for resection
- At least one tumor size >=3cm
- Performance status 0-1
Exclusion Criteria:
- Liver cirrhosis
- Extrahepatic metastases that can not be addressed curatively
- Other malignant diseases within 5 years prior to diagnosis
- Prior RFA treatment
Sites / Locations
- Aarhus University Hospital, Department of SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention (+RFA) arm
Control (-RFA) arm
Arm Description
Preoperative partial RFA necrosis in the liver metastasis followed by liver resection
Liver resection
Outcomes
Primary Outcome Measures
Overall survival
Median survival in each arm
Secondary Outcome Measures
One-year survival
One-year survival in each arm
Two-year survival
Two-year survival in each arm
Three-year survival
Three-year survival in each arm
Recurrence rate
Recurrence rate at 1, 2, and 3 years follow-up
Full Information
NCT ID
NCT04798898
First Posted
March 9, 2021
Last Updated
November 16, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT04798898
Brief Title
Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
Acronym
ISCOLIM
Official Title
Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 14, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To examine radio frequency ablation as a treatment supplement to stimulate immunogenicity and improve survival for patients undergoing curative-intent surgery for colorectal liver metastases.
Detailed Description
PURPOSE:
To investigate the impact of immunostimulation using radio frequency ablation (RFA) on survival in patients undergoing curative-intent surgery for colorectal liver metastases (CRLM).
HYPOTHESIS:
RFA-mediated partial destruction of CRLM will stimulate the immune system to recognize otherwise hidden cancer antigens, which in turn will improve survival by inhibiting micrometastases and recurrence.
BACKGROUND:
CRLM affects around 1,600 individuals in Denmark each year. State-of-the-art treatment includes liver resection, RFA treatment, radiation therapy, and chemotherapy. Of all individuals undergoing surgery, 50% will experience local or distant recurrence of the disease within five years. Although liver resection is the gold standard, RFA treatment has evolved considerably in recent years. RFA is a parenchymal-sparing treatment for hepatic malignancies, inducing a localized coagulation necrosis of the tumor. This leads to release of tumor antigens, which activates the patients' immune system. However, many cancer cells, including those from CRLM, have the ability to hide their antigens to the patients' immune systems. Using RFA as immunostimulation prior to surgery, these antigens may become visible to the immune system, which in turn can help eradicating all tumor cells and decrease the risk of tumor recurrence. Combined, this likely improves survival.
METHODS:
220 patients with CRLM planned for surgery will be enrolled in this study. Patients will be randomized to +/- RFA treatment before surgery. Under guidance of ultrasonography, a single-electrode RFA-needle is placed in a CRLM with a diameter of at least 3 cm, which is later going to be resected. In 20 of the patients, we will draw blood samples for determination of immune status both pre- and postoperatively. All patients will be part of a work-up with regular CT-scans.
ENDPOINTS:
Disease free survival and overall survival. Secondarily, we will examine the effect of RFA treatment of tumors on the innate and adaptive immune system in 20 patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Metastasis Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention (+RFA) arm
Arm Type
Experimental
Arm Description
Preoperative partial RFA necrosis in the liver metastasis followed by liver resection
Arm Title
Control (-RFA) arm
Arm Type
No Intervention
Arm Description
Liver resection
Intervention Type
Device
Intervention Name(s)
RFA (radiofrequency ablation)
Intervention Description
Preoperative RFA-induced partial necrosis of the liver metastasis
Primary Outcome Measure Information:
Title
Overall survival
Description
Median survival in each arm
Time Frame
3 years
Secondary Outcome Measure Information:
Title
One-year survival
Description
One-year survival in each arm
Time Frame
1 year
Title
Two-year survival
Description
Two-year survival in each arm
Time Frame
2 years
Title
Three-year survival
Description
Three-year survival in each arm
Time Frame
3 years
Title
Recurrence rate
Description
Recurrence rate at 1, 2, and 3 years follow-up
Time Frame
1, 2, and 3 years
Other Pre-specified Outcome Measures:
Title
Complications
Description
Immediate postoperative complications (bleeding, surgical site infection, intraabdominal abscesses, bile leak)
Time Frame
30-day postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with colorectal liver metastases planned for resection
At least one tumor size >=3cm
Performance status 0-1
Exclusion Criteria:
Liver cirrhosis
Extrahepatic metastases that can not be addressed curatively
Other malignant diseases within 5 years prior to diagnosis
Prior RFA treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakob Kirkegård, MD, PhD
Phone
+4524995027
Email
jakob.kirkegaard@auh.rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank V Mortensen, MD, DMSc
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital, Department of Surgery
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakob Kirkegård, MD, PhD
Email
jakob.kirkegaard@auh.rm.dk
First Name & Middle Initial & Last Name & Degree
Frank V Mortensen, MD, DMSc
First Name & Middle Initial & Last Name & Degree
Jakob Kirkegård, MD, PhD
First Name & Middle Initial & Last Name & Degree
Andrea Lund, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Survival of COlorectal LIver Metastases by RFA-mediated Immunostimulation
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