Ablation With Confirmation of Colorectal Liver Metastases (ACCLAIM)

Launched by SOCIETY OF INTERVENTIONAL ONCOLOGY · Feb 22, 2022

Keywords

ClinConnect Summary

The ACCLAIM trial is studying a treatment called microwave ablation (MWA) for patients with colorectal cancer that has spread to the liver. The goal of the study is to see if this treatment can help at least 90% of participants live for two years without their liver tumors growing again. To be eligible for the trial, participants must be at least 18 years old and have confirmed colorectal cancer with up to three liver tumors, each no larger than 2.5 centimeters. They should also be healthy enough to undergo the procedure.

Participants in the trial can expect to receive microwave ablation, which uses heat to destroy cancer cells, and they will be closely monitored for their progress over time. It’s important to note that this study is currently recruiting participants, and anyone considering joining should discuss it with their doctor to see if they meet the criteria and if it’s the right option for them.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patient must be at least 18 years old.
• • 2. Patient has signed a written informed consent for the MWA and participation in the study.
• • 3. Patient with pathologically confirmed CRC with hepatic metastases confirmed on imaging (e.g., CT or MRI).
• • 4. Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter.
• • 5. 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
• • 6. 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.
• • 7. 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.
• • 8. ECOG performance status of 0-1.
• • 9. Platelet count \>50,000/mm3 (correctable allowed) within 30 days prior to study treatment.
• Exclusion Criteria:
• • 1. Patient is unable to lie flat or has respiratory distress at rest.
• • 2. Patient has uncontrolled and uncorrectable coagulopathy or bleeding disorders.
• • 3. 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.
• • 4. Patient has evidence of active systemic infection.
• • 5. Patient has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
• • 6. Patient is currently participating in other experimental studies that could affect the primary endpoint.
• • 7. Patient unable to receive general anesthesia or adequate analgesia and sedation.
• • 8. Tumor location less than 25 mm from hilum (see diagrams with illustration of central ducts).
• • 9. Patient is currently pregnant or intends to become pregnant