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Anti-tumor antibiotic
TACE + SBRT for Liver Cancer (TACE Trial)
Phase 3
Recruiting
Led By Michael Lock, M.D.
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All intrahepatic disease must be amenable to TACE
All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
TACE Trial Summary
This trial is testing whether adding a specialized radiation treatment to the standard chemotherapy treatment for liver cancer will help control the cancer better.
Who is the study for?
This trial is for adults with liver cancer, having up to 5 liver lesions and no severe cirrhosis or active hepatitis. They must not have had certain treatments recently, be able to use contraception, and have a life expectancy over 6 months. Those with larger tumors or previous radiation in the same area can't join.Check my eligibility
What is being tested?
The study compares standard TACE treatment for liver cancer against TACE combined with SBRT, a precise radiation therapy. It aims to see if adding SBRT better controls the growth of liver tumors after TACE.See study design
What are the potential side effects?
TACE can cause abdominal pain, fever, nausea, and liver problems. SBRT might add side effects like fatigue, skin reactions at the treatment site, and potential damage to nearby organs.
TACE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer can be treated with TACE.
Select...
All my liver cancer can be targeted with radiation.
Select...
I finished chemotherapy at least 2 weeks ago and won't start again for at least 1 week after my next treatment.
Select...
I have liver cancer with specific blood test results and liver condition.
Select...
My scans show liver spots, suggesting cancer spread, but my earlier liver scans were clear.
Select...
I can take care of myself, but I cannot do heavy physical work.
Select...
My liver or bile duct cancer is confirmed by lab tests.
Select...
My liver cancer or liver spread is 25 cm or smaller.
Select...
I am older than 18 years.
Select...
My liver cancer is not lymphoma and has been confirmed by a biopsy.
Select...
My condition cannot be treated with surgery.
TACE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Time to Intrahepatic Progression
Secondary outcome measures
Change in Health related Quality of Life (QOL)
Cost-benefit
Extrahepatic failure
+9 moreTACE Trial Design
2Treatment groups
Active Control
Group I: Transarterial Chemoembolization (TACE)Active Control1 Intervention
Transarterial Chemoembolization (TACE)
Group II: TACE Plus Stereotactic Body Radiation Therapy (SBRT)Active Control1 Intervention
Stereotactic Body Radiation Therapy (SBRT)
Find a Location
Who is running the clinical trial?
CancerCare ManitobaOTHER
28 Previous Clinical Trials
5,540 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
659 Previous Clinical Trials
413,604 Total Patients Enrolled
Michael Lock, M.D.Principal InvestigatorLawson Health Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation in the same area where my current cancer is located.My liver cancer can be treated with TACE.All my liver cancer can be targeted with radiation.I have had surgery or treatment to remove or destroy liver tissue.My liver is not severely damaged (Child Pugh ≤ B7).My liver cancer is considered life-limiting even if I have cancer elsewhere.I finished chemotherapy at least 2 weeks ago and won't start again for at least 1 week after my next treatment.I have liver cancer with specific blood test results and liver condition.My health issues do not limit my life expectancy to under 6 months.My scans show liver spots, suggesting cancer spread, but my earlier liver scans were clear.I am not pregnant, nursing, or able to become pregnant and will use birth control during the study.I do not have active hepatitis or significant liver failure.I can take care of myself, but I cannot do heavy physical work.My liver or bile duct cancer is confirmed by lab tests.My liver tumor or metastasis is larger than 25 cm.I have 5 or fewer liver tumors that can be seen on a recent scan.My liver cancer or liver spread is 25 cm or smaller.I am older than 18 years.My liver cancer is not lymphoma and has been confirmed by a biopsy.My condition cannot be treated with surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Transarterial Chemoembolization (TACE)
- Group 2: TACE Plus Stereotactic Body Radiation Therapy (SBRT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are doctors and researchers hoping to study and discover through this clinical trial?
"The success of this clinical trial will be judged by the patients' Overall Survival rates, which will be measured before treatment, 1 month, 3 months, and then every 3 months up to 2 years. Additionally, the Radiation Therapy Classic Radiation Toxicity Assessment (defined as Classic RILD), the Response Rate (defined as Modified RECIST), and the Radiation Therapy Overall Toxicity Assessment (defined as CTC V4.0) will be secondary measures of success."
Answered by AI
How many individuals are partaking in this clinical trial?
"The trial is ongoing and is currently looking for 128 patients at a single site, according to the listing on clinicaltrials.gov. This particular study was first posted on 5/27/2019, with the most recent update on 11/10/2021."
Answered by AI
Does the FDA recognize TACE Plus Stereotactic Body Radiation Therapy (SBRT) as an effective treatment?
"TACE Plus Stereotactic Body Radiation Therapy (SBRT) is estimated to be a 3 on a scale of 1 to 3 in terms of safety."
Answered by AI
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