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Ablation
Microwave Ablation for Liver Cancer (ACCLAIM Trial)
N/A
Recruiting
Led By Constantinos Sofocleous, MD, PhD, FSIR, FCIRSE
Research Sponsored by Society of Interventional Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has up to 3 hepatic metastases, each up to 2.5 cm in largest diameter
Patient must be at least 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
ACCLAIM Trial Summary
This trialtests if a procedure (MWA) can safely treat up to 3 small liver tumors with a good chance of long-term success.
Who is the study for?
This trial is for adults with colorectal cancer that has spread to the liver, with up to 3 small liver tumors (each ≤2.5 cm). Participants can have a few small lung lesions or lymph nodes and must be in good physical condition (ECOG 0-1). They should not have severe illnesses, uncontrolled bleeding disorders, allergies to IV iodine that can't be managed, active infections, or be pregnant.Check my eligibility
What is being tested?
The ACCLAIM study tests microwave ablation on small liver metastases from colorectal cancer. The goal is to see if this treatment can stop tumor growth for at least two years in 90% of cases without surgery or other interventions.See study design
What are the potential side effects?
Microwave ablation may cause pain at the treatment site, burns on the skin or internal organs near the treated area, infection risks post-procedure and possible damage to nearby structures due to heat exposure.
ACCLAIM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have up to 3 liver tumors, each no larger than 2.5 cm.
Select...
I am 18 years old or older.
Select...
My colorectal cancer has spread to my liver, confirmed by scans.
Select...
I am fully active or can carry out light work.
ACCLAIM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local tumor progression free survival at 24 months
Secondary outcome measures
Hepatic progression free survival by Kaplan-Meier estimate
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
Overall and disease specific survival following MWA using Kaplan-Meier methodology
+3 moreACCLAIM Trial Design
1Treatment groups
Experimental Treatment
Group I: Microwave ablation with margin confirmationExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Microwave ablation
2011
N/A
~660
Find a Location
Who is running the clinical trial?
Society of Interventional OncologyLead Sponsor
1 Previous Clinical Trials
9,585 Total Patients Enrolled
Constantinos Sofocleous, MD, PhD, FSIR, FCIRSEPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor is close to the central part of my lung.I have up to 3 liver tumors, each no larger than 2.5 cm.I cannot lie flat or have trouble breathing when resting.I am 18 years old or older.I currently have an active infection in my body.I have a bleeding disorder that cannot be controlled or corrected.I have up to 5 small lung lesions or small lymph nodes.My colorectal cancer has spread to my liver, confirmed by scans.I am fully active or can carry out light work.My tumor can be safely targeted with a treatment that heats and destroys it, leaving a small safety margin.I cannot have general anesthesia or enough pain relief and sedation.My tumor can be seen on ultrasound or CT scan and can be safely targeted for microwave ablation.
Research Study Groups:
This trial has the following groups:- Group 1: Microwave ablation with margin confirmation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are eligible to participate in this clinical research?
"Affirmative. According to the clinicaltrial.gov website, this research project is currently accepting applicants; it was initially posted on January 13th 2023 and updated most recently on February 8th 2023. In total, 275 participants will be recruited from two distinct medical sites."
Answered by AI
Is there an opportunity to join this medical experiment at the moment?
"Currently, the study is actively recruiting participants. This trial was initially advertised on January 13th of 2023 and has had its most recent update as recently as February 8th of this year."
Answered by AI
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