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Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) (ACCLAIM)

Primary Purpose

Colorectal Liver Metastases

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Microwave ablation

About this trial

This is an interventional treatment trial for Colorectal Liver Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient must be at least 18 years old.
Patient has signed a written informed consent for the MWA and participation in the study.
Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).
Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any lymph node ≤2.0 cm in the largest diameter
Ability to safely create an ablation zone (AZ) that completely covers the tumor with minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule) or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be included. For these tumors, the calculation of the margin will not apply to the area abutting the capsule or the vessel.
The target tumor(s) is/are visible by US and/or CT in a location where MWA is technically achievable and safe based on the proximity to adjacent structures. Protective maneuvers such as hydrodissection for organ mobilization are allowed and will be recorded.
ECOG performance status of 0-1.
Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study treatment.

Exclusion Criteria:

Patient is unable to lie flat or has respiratory distress at rest.
Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast.
Patient has evidence of active systemic infection.
Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
Patient is currently participating in other experimental studies that could affect the primary endpoint.
Patient unable to receive general anesthesia or adequate analgesia and sedation.
Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts).
Patient is currently pregnant or intends to become pregnant

Sites / Locations

Miami Cancer InstituteRecruiting
Mayo ClinicRecruiting
Memorial Sloan Kettering Cancer CenterRecruiting
MD Anderson Cancer CenterRecruiting
Medical College of WIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave ablation with margin confirmation

Arm Description

Patients who meet the eligibility criteria will undergo microwave ablation (MWA) of 1-3 colorectal cancer metastases with any FDA cleared/CE Marked Microwave Ablation System in accordance with the study site's standard-of-care (SOC) practices.

Outcomes

Primary Outcome Measures

Local tumor progression free survival at 24 months

See Above

Secondary Outcome Measures

Hepatic progression free survival by Kaplan-Meier estimate

See Above

Local tumor progression free survival between sufficient (5.0-9.9 mm) and ideal (≥10 mm) ablation margin categories using Kaplan-Meier methodology and the log-rank test

See Above

Progression free survival using Kaplan-Meier methodology and the log-rank test

See Above

Overall and disease specific survival following MWA using Kaplan-Meier methodology

See Above

Proportion of target tumors treated with an ablation zone (AZ) that completely covers the target tumor(s) with minimal margin (MM) of at least 5 mm

See Above

Proportion of subjects with CTCAE grade 3 events or greater within 90 days after MWA

See Above

Full Information

NCT ID

NCT05265169

First Posted

February 22, 2022

Last Updated

May 31, 2023

Sponsor

Society of Interventional Oncology

1. Study Identification

Unique Protocol Identification Number

NCT05265169

Brief Title

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

Acronym

ACCLAIM

Official Title

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM) Prospective Trial for Microwave Ablation as a Local Cure

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 13, 2023 (Actual)

Primary Completion Date

November 11, 2027 (Anticipated)

Study Completion Date

December 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Society of Interventional Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

To demonstrate that microwave ablation (MWA) of up to 3 hepatic metastases, each with a maximum diameter of ≤ 2.5 cm will result in a 2-year local progression free survival of at least 90%. This is a standard of care (SOC) study.

Detailed Description

In this prospective, multi-center, standard of care trial we propose to establish microwave ablation (MWA) as the preferred curative therapy for selected colorectal liver metastases (CLM) that can be ablated with sufficient margins. Our hypothesis is that MWA of CLM ≤ 2.5 cm with confirmation of ablation margin over 5 mm achieves definitive local tumor control (local cure) with minimal morbidity. This international study will enroll subjects with one to three CLMs (for a total of 330 tumors/approximately 275 subjects) eligible for local cure using MWA. Any FDA cleared or CE Marked MWA device will be acceptable for use. MWA will be performed with the intent to create a minimum margin of ablation of 5.0 mm and ideally ≥10 mm from the edge of the target tumor to the ablation periphery. Minimum margin (MM) size will be documented intra-procedurally (immediately post MWA with contrast-enhanced CT) and again within 4-8 weeks after MWA. Assessment of the MM will be conducted by an independent core lab using an FDA approved/cleared image-processing software to provide 3D assessment of the ablation zone and margin. The initial assessment of the MM by the core lab will be conducted within 7 days of the MWA and again within 7 days after SOC imaging 4-8 weeks post MWA A minimal ablation margin of 5.0 mm will represent the necessary condition for technical success of the ablation. Margin assessment will be verified by an independent physician reviewer. For MMs less than 5 mm, repeat MWA will be performed whenever feasible/safe, within 30 days from detection, in order to achieve sufficient MM (> 5mm). Minimum margin size will be correlated with time to local tumor progression. Local disease-free progression (within or abutting the ablation zone) and hepatic disease-free survival (accounting for all tumors ablated) stratified by MM of ≥ 5.0-9.9 mm and ≥ 10.0 mm will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Liver Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, open-label multicenter trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Microwave ablation with margin confirmation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Microwave ablation

Intervention Description

Microwave ablation of colorectal liver metastases (CLM)

Primary Outcome Measure Information:

Title

Local tumor progression free survival at 24 months

Description

See Above

Time Frame

24 Months

Secondary Outcome Measure Information:

Title

Hepatic progression free survival by Kaplan-Meier estimate

Description

See Above

Time Frame

24 Months

Title

Local tumor progression free survival between sufficient (5.0-9.9 mm) and ideal (≥10 mm) ablation margin categories using Kaplan-Meier methodology and the log-rank test

Description

See Above

Time Frame

24 Months

Title

Progression free survival using Kaplan-Meier methodology and the log-rank test

Description

See Above

Time Frame

24 Months

Title

Overall and disease specific survival following MWA using Kaplan-Meier methodology

Description

See Above

Time Frame

24 Months

Title

Proportion of target tumors treated with an ablation zone (AZ) that completely covers the target tumor(s) with minimal margin (MM) of at least 5 mm

Description

See Above

Time Frame

24 Months

Title

Proportion of subjects with CTCAE grade 3 events or greater within 90 days after MWA

Description

See Above

Time Frame

90 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient must be at least 18 years old. Patient has signed a written informed consent for the MWA and participation in the study. Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI). Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter. Patient may have up to 5 lesions in the lung (none larger than ≥ 2.0 cm) and/or any lymph node ≤2.0 cm in the largest diameter Ability to safely create an ablation zone (AZ) that completely covers the tumor with minimal margin of 5.0 mm. Subcapsular (any tumor within 10 mm from the liver capsule) or perivascular (any tumor within 10 mm from a vessel larger than 3 mm) lesions may be included. For these tumors, the calculation of the margin will not apply to the area abutting the capsule or the vessel. The target tumor(s) is/are visible by US and/or CT in a location where MWA is technically achievable and safe based on the proximity to adjacent structures. Protective maneuvers such as hydrodissection for organ mobilization are allowed and will be recorded. ECOG performance status of 0-1. Platelet count >50,000/mm3 (correctable allowed) within 30 days prior to study treatment. Exclusion Criteria: Patient is unable to lie flat or has respiratory distress at rest. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders. Patient has a history of an allergic reaction to intravenous iodine that cannot be pre-medicated or prevents performance of a CT with IV contrast. Patient has evidence of active systemic infection. Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up. Patient is currently participating in other experimental studies that could affect the primary endpoint. Patient unable to receive general anesthesia or adequate analgesia and sedation. Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts). Patient is currently pregnant or intends to become pregnant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Research Manager

Phone

202-367-1164

ACCLAIM@SIO-central.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Miami Cancer Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny Camus

Phone

786-527-8151

Juana.Camus@baptisthealth.net

First Name & Middle Initial & Last Name & Degree

Govindarajan Narayanan, MD

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Desirae Howe-Clayton

Phone

507-255-0111

howe.desirae@mayo.edu

First Name & Middle Initial & Last Name & Degree

Grant Schmit, MD

First Name & Middle Initial & Last Name & Degree

Anil Kurup, MD

First Name & Middle Initial & Last Name & Degree

Matt Callstrom, MD, PhD

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadia Petree

petree@mskcc.org

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria C Briones Dimayuga, MD

Phone

832-792-1692

mcbrione@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Barom J Aromin, RN

Phone

2817877562

BJAromin@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Bruno C Odisio, MD

Facility Name

Medical College of WI

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dawn Carini

Phone

414-955-0212

dcarini@mcw.edu

First Name & Middle Initial & Last Name & Degree

Amanda Smolock, MD

First Name & Middle Initial & Last Name & Degree

William Rilling, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

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