Hepatocellular CarcinomaPhase 3SBRTvsTACENCT03960008
Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
A Phase 3 study testing Stereotactic Body Radiation Therapy (SBRT), Trans-Arterial Chemoembolization (TACE) and Doxorubin in people with Hepatocellular Carcinoma and HCC, run by Lahey Clinic at 5 sites in 2 countries.
Trial summary
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, HCC
- What is being tested?
- Stereotactic Body Radiation Therapy (SBRT), Trans-Arterial Chemoembolization (TACE) and Doxorubin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Mar 2020to 28 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
- Biopsy proven HCC or:
- A discrete hepatic tumor(s) as defined by the Barcelona (29) criteria for cirrhotic subjects, ≥2cm with arterial hypervascularity and venous or delayed phase washout on CT or MRI.
- Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.
- Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.
- Subjects must be eligible per standard of care for either TACE or SBRT procedures.
Show all 17Show fewer
- Subjects must have a life expectancy of at least 12 weeks.
- Subjects must be 18 years of age or older. Adult subjects of all ages, both sexes and all races will be included in this study.
- Subjects must sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of record .
- Subjects must have a Child-Turcotte-Pugh (CTP) score ≤8.
- Patients must have adequate organ function within 2 weeks of enrollment.
- Bone marrow: Platelets ≥30,000/mm3
- Renal: BUN ≤40 mg/dl; creatinine ≤2.0 mg/dl
- Hepatic: INR ≤ 1.5 or correctable by Vitamin K, unless anti-coagulated for another medical reason
- Bilirubin < 3.0 mg/dl (in the absence of obstruction or pre-existing disease of the biliary tract, e.g. primary sclerosing cholangitis).
- Patients uninvolved liver volume will be estimated and must be > 700ml.
- Patients must have a Zubrod performance status of ≤2.
Who cannot join
- Subjects in a "special category" designated by the Public Health Service, Including subjects younger than 18, pregnant women, and prisoners.
- Refractory ascites that requires paracentesis for management.
- Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
- History of prior radiation to the liver.
- Evidence of metastatic disease.
- Presence of a Trans-jugular intra-hepatic porto-systemic shunt (TIPS).
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43202
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.
Read the detailed description
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.
- Conditions
- Hepatocellular Carcinoma, HCC
- Being tested
- Stereotactic Body Radiation Therapy (SBRT), Trans-Arterial Chemoembolization (TACE), Doxorubin
- Keywords
- Hepatocellular Carcinoma (HCC), Liver transplant, Bridge to transplant, Stereotactic body radiation therapy (SBRT), Trans-arterial chemoembolization (TACE)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy (SBRT)Radiation
Also called Radiation Therapy
SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.
Trans-Arterial Chemoembolization (TACE)Procedure or surgery
Also called Chemoembolization
First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation
DoxorubinDrug
Also called Doxorubin bead therapy
This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Other | Radiation Therapy Receives: Radiation: Stereotactic Body Radiation Therapy (SBRT) |
| Trans-Arterial Chemoembolization (TACE) | Other | Procedure/Surgery - Chemoembolization Drug: Doxorubin Receives: Procedure: Trans-Arterial Chemoembolization (TACE); Drug: Doxorubin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation
To compare whether or not there was disease present in treated lesions in both the SBRT and TACE arms in patients eligible for liver transplant at 1 year post treatment.
Measured: 1 year post treatment
Secondary outcomes (8)
To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
To compare treatment related adverse events between both arms, SBRT and TACE.
Measured: At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
Number of Further Interventions
To compare the number of further interventions between the SBRT and TACE arms.
Measured: 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
Rate of Pathological Response of Treated Lesion(s)
Complete pathologic response of lesions will be analyzed on the explant liver specimen after liver transplant. The pathology note will be consulted.
Measured: Review of pathology report after liver transplant
Rate of Radiological Response of Treated Lesion(s)
Response of treated lesions will be analyzed at protocol specified time frames. The response rate between both treatment arms will be compared.
Measured: Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment
To Assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
A 45-item self-report instrument to measure health-related quality of life (HRQL) in patients with hepatobiliary cancers and is one of the most widely-used instruments in this clinical area. The FACT-Hep consists of the 27-item FACT-G, assesses HRQL, and the 18-item Hepatobiliary Subscale (HS), assesses disease-specific issues such as pain, appetite, and cramping. The FACT-G evaluates physical well-being, social/family well-being, emotional well-being, and functional well-being. Sections have a 7-day reference period and are scored from 0-4 ("not at all" to "very much"), with higher scores indicating better HRQL. Score ranges are 0-28 for physical well-being, 0-28 for social/family well-being, 0-24 for emotional well-being, 0-28 for functional well-being, and 0-72 for the HS. All subscale scores from the FACT-G and HS can be summed together to create a total FACT-Hep score, with a possible range of 0-180. The FACT-Hep takes approximately 10 minutes to complete.
Measured: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment
To Assess Over Survival
Overall survival will be compared in both arms at protocol specified time frames.
Measured: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment
To Assess 90 Day Post-transplant Morbidity
Compare the morbidity at 90 days post transplant between both arms.
Measured: Disease status to be captured 90 days post-transplantation (+/- 2 weeks)
To Assess 90 Day Post-transplant Mortality
Will assess the mortality of post-transplant patients between the two arms.
Measured: Survival status to be captured 90 days post-transplantation (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 Mar 2020
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: This study was closed early due to lack of enrollments and insufficient funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems, Merit Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Corrine Zarwan, MD, Principal investigator, Lahey Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960008
- Sponsor's protocol ID
- 20193013
- Acronym
- SBRTvsTACE
- Status last verified
- Aug 2024
- First submitted
- 30 Apr 2019
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multi-Center Phase III Study of Individualized Stereotactic Body Radiation Therapy (SBRT) Versus Trans-Arterial Chemoembolization (TACE) as a Bridge to Transplant in Hepatocellular Carcinoma.
- ClinicalTrials.gov ID
- NCT03960008
- Acronym / sponsor ID
- SBRTvsTACE / 20193013
- Conditions
- Hepatocellular Carcinoma, HCC
- Keywords
- Hepatocellular Carcinoma (HCC), Liver transplant, Bridge to transplant, Stereotactic body radiation therapy (SBRT), Trans-arterial chemoembolization (TACE)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed early due to lack of enrollments and insufficient funding.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Collaborators
- Varian Medical Systems, Merit Medical Systems, Inc.
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 28 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare stereotactic body radiation therapy (SBRT) to trans-arterial chemoembolization (TACE) as a bridging strategy for patients with HCC undergoing liver transplantation. We propose that SBRT will be associated with longer time intervals between initial treatment and the need for retreatment, compared to TACE, as a "bridge" to liver transplantation in subjects with HCC.
Detailed description
For patients with hepatocellular carcinoma (HCC) who are waiting for a liver transplant, local treatment of their disease has become the standard of care in an effort to decrease dropout rates and as a means of reducing tumor recurrence after transplantation. For patients undergoing local regional therapy as a bridge to transplantation, trans-arterial chemoembolization (TACE) is the most commonly utilized treatment. However, the best modality for patients undergoing treatment as a bridge to transplantation is unclear. A newer strategy for the treatment of HCC is stereotactic body radiation therapy (SBRT). This study will compare SBRT to TACE as a bridging strategy for patients with HCC undergoing liver transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Other | Radiation: Stereotactic Body Radiation Therapy (SBRT)Radiation Therapy |
| Trans-Arterial Chemoembolization (TACE) | Other | Procedure: Trans-Arterial Chemoembolization (TACE), Drug: DoxorubinProcedure/Surgery - Chemoembolization Drug: Doxorubin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
- Subjects are liver transplant candidates (actively awaiting organ transplant per transplant services in documentation), or, potential liver transplant candidates (at the discretion of the liver team and/or Principal Investigator) advised by liver transplant services as needing local treatment prior to liver transplant evaluation.
- Subjects must be within UCSF criteria (one solitary tumor smaller than 6.5 cm, or patients having 3 or fewer nodules, with the largest lesion being smaller than 4.5 cm or having a total tumor diameter less than 8.5 cm without vascular invasion) and eligible for potential liver transplant.
- Subjects must be eligible per standard of care for either TACE or SBRT procedures.
- Subjects must have a life expectancy of at least 12 weeks.
Key exclusion criteria (6 listed)
- Subjects in a "special category" designated by the Public Health Service, Including subjects younger than 18, pregnant women, and prisoners.
- Refractory ascites that requires paracentesis for management.
- Known allergy to intravenous iodinated contrast agents unresponsive to prednisone pre-treatment.
- History of prior radiation to the liver.
- Evidence of metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT)Also: Radiation TherapySBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days. | Radiation | Stereotactic Body Radiation Therapy (SBRT) |
| Trans-Arterial Chemoembolization (TACE)Also: ChemoembolizationFirst day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation | Procedure or surgery | Trans-Arterial Chemoembolization (TACE) |
| DoxorubinAlso: Doxorubin bead therapyThis procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin. | Drug | Trans-Arterial Chemoembolization (TACE) |
Primary outcome
To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation
Time frame: 1 year post treatment
To compare whether or not there was disease present in treated lesions in both the SBRT and TACE arms in patients eligible for liver transplant at 1 year post treatment.
8 secondary outcomes
To Compare Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Time frame: At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
Number of Further Interventions
Time frame: 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatment
Rate of Pathological Response of Treated Lesion(s)
Time frame: Review of pathology report after liver transplant
Rate of Radiological Response of Treated Lesion(s)
Time frame: Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatment
To Assess Quality of Life by Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) Questionnaire
Time frame: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment
To Assess Over Survival
Time frame: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatment
To Assess 90 Day Post-transplant Morbidity
Time frame: Disease status to be captured 90 days post-transplantation (+/- 2 weeks)
To Assess 90 Day Post-transplant Mortality
Time frame: Survival status to be captured 90 days post-transplantation (+/- 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corrine Zarwan, MD principal investigator
Lahey Hospital & Medical Center
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stereotactic Body Radiation Therapy (SBRT), Trans-Arterial Chemoembolization (TACE) and Doxorubin in people with Hepatocellular Carcinoma and HCC, run by Lahey Clinic at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Compare the Duration of Disease Control in Treated Lesions When Utilizing SBRT Versus TACE as a Bridging Strategy for Patients With HCC Eligible for Liver Transplantation (time frame: 1 year post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.