- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895359
Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Liver Carcinoma (TACE)
A Phase III Randomized Trial of Transarterial Chemoembolization (TACE) Versus TACE Plus Stereotactic Body Radiation Therapy (SBRT) in Primary or Secondary Liver Carcinoma
Trans-arterial chemoembolization (TACE) is a standard treatment for patients with hepatocellular carcinoma (also called liver cancer). This is where chemotherapy is injected into the arteries of the liver and liver cancer. Unfortunately, the tumour grows after TACE in many patients.
A new treatment using a specialized radiation procedure called Stereotactic ablative body radiotherapy (SBRT) may increase the chance to control liver cancer. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. The purpose of this study is to find out if TACE alone versus TACE plus SBRT is better for you and your liver cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Michael Lock, M.D.
- Phone Number: 519-685-8650
- Email: michael.lock@lhsc.on.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 5W9
- Recruiting
- London Health Sciences Centre, London Regional Cancer Program
-
Contact:
- Michael Lock, M.D.
- Phone Number: 519-685-8650
- Email: michael.lock@lhsc.on.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary hepatobiliary cancer confirmed pathologically
- Non - lymphoma liver metastases confirmed pathologically
- Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non - lymphoma cancer and a previously negative CT or MRI of the liver
- Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis.
- ≤ 5 liver lesions measurable on a contrast - enhanced liver CT or MRI performed within 90 days prior to study entry.
- Primary liver lesion or liver metastases measuring ≤ 25 cm.
- Extrahepatic cancer is permitted if liver involvement is judged to be life - limiting.
- All intrahepatic disease must be encompassed within the radiation fields according to protocol criteria.
- Patient must be judged medically or surgically unresectable
- Zubrod Performance Scale = 0 - 3
- Age > 18
- All intrahepatic disease must be amenable to TACE
- Previous liver resection or ablative therapy is permitted.
- Chemotherapy must be completed at least 2 weeks prior to radiation therapy or TACE, and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment.
- Life expectancy > 6 months.
- Women of childbearing potential and male participants must practice adequate contraception.
- Patient must sign study specific informed consent prior to study entry.
Pretreatment Evaluations Required for Eligibility:
- A complete history and general physical examination.
- CBC, INR, Total bilirubin, albumin, alkaline phosphatase, ALT, AST within 4 weeks prior to study entry. Appropriate levels are as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells / mm3
- Platelets ≥ 70,000 cells / mm3
- Hemoglobin ≥ 8.0 g / dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g / dl is acceptable.)
- Total bilirubin < 3 mg / dL
- Prothrombin time / INR < 2 (if not on anticoagulants)
- Albumin ≥ 28 g / L
- AST and ALT < 10 times ULN
Exclusion Criteria:
- Severe cirrhosis or liver failure defined as Child Pugh > B7
- Primary liver tumor or liver metastasis > 25 cm in maximal dimension.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Severe, active co-morbidity, defined as limiting the patients life to less than 6 months
- Active hepatitis or clinically significant liver failure.
- Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be teratogenic.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transarterial Chemoembolization (TACE)
|
Transarterial chemoembolization is a standard treatment for patients with hepatocellular carcinoma (liver cancer).
Chemotherapy is injected into the arteries of the liver and liver cancer.
Other Names:
|
Active Comparator: TACE Plus Stereotactic Body Radiation Therapy (SBRT)
Stereotactic Body Radiation Therapy (SBRT)
|
For patients randomized to the SMRT arm, SBRT is to be delivered over 5 fractions delivered over 5 to 15 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: At 2 years from start of treatment
|
Overall Survival-number of patients alive censored for deaths by any cause
|
At 2 years from start of treatment
|
Time to Intrahepatic Progression
Time Frame: Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years
|
This will be measured using the modified RECIST (Response evaluation criteria in solid tumors) criteria
|
Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Response Rate
Time Frame: The sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor.
|
Modified RECIST (Response Evaluation Criteria in Solid Tumors) criteria
|
The sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor.
|
Local Failure
Time Frame: 5 years
|
Within 1 cm from the original tumor volume
|
5 years
|
Extrahepatic failure
Time Frame: Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years
|
This will be defined as any lesion found to be new or progressing outside the hepatic organ.
|
Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years
|
Time to intrahepatic progression
Time Frame: Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years
|
This will be measured using the modified RECIST (Response evaluation criteria in solid tumors) criteria
|
Pre-treatment, at 1 month and 3 month follow-up, and at follow-up every 3 months up to 2 years
|
Radiation Therapy Overall Toxicity Assessment
Time Frame: Weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
CTC V4.0 (Common Terminology Criteria version 4.0)
|
Weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Radiation Therapy Classic Radiation Toxicity Assessment
Time Frame: Weekly during treatment , 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Classic RILD (Radiation-induced liver disease)
|
Weekly during treatment , 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Radiation Therapy Non-Classic Toxicity Assessment
Time Frame: Weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Non-classic RILD (Radiation-induced liver disease)
|
Weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Radiation Therapy Toxicity Assessment
Time Frame: Patients will be assessed at least once during radiation therapy for toxicity
|
Measured using Child-Pugh score to indicate the severity of toxicity.
Five variables are considered: presence of ascites, encephalopathy, serum levels of albumin, total bilirubin and prolongation of the clotting time.
Each of these variables is assigned a score between 1 and 3 according to its severity or degree of abnormality.
The sum of the five scores is used to assign a "Child-Pugh grade" of A, B or C to the patient's clinical condition at that point in time.
Grade A indicates a well-functioning liver, Grade B indicates significant functional compromise, Grade C indicates decompensation of the liver.
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Patients will be assessed at least once during radiation therapy for toxicity
|
Change in Health related Quality of Life (QOL)
Time Frame: Pre-Treatment, weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter
|
Measured using the EORTC (European Organisation for Research and Treatment of Cancer) QLQ H&N35 (Quality of Life Questionnaire Head & Neck).
According to the EORTC scoring guidelines All of the scales and single-item measures range in score from 0 to 100.
A high scale score represents a higher response level.
Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
|
Pre-Treatment, weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter
|
Overall Quality of Life (QOL)
Time Frame: Pre-Treatment, weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
QLQC30 (Quality of Life Questionnaire version 3)
|
Pre-Treatment, weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Liver Related Quality of Life (QOL)
Time Frame: Pre-Treatment, weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
FACT-L (Functional Assessment of Cancer Therapy-Lung)
|
Pre-Treatment, weekly during treatment, 1 and 3 month follow-up, and every 3 months thereafter up to 2 years
|
Cost-benefit
Time Frame: Through study completion, an average of 2 years
|
A cost benefit analysis will be used to evaluate the total anticipated cost of the project and compare it to the total expected benefits.
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Lock, M.D., Lawson Health Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TACE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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