A Phase 3 interventional study of Stereotactic Body Radiation Therapy (SBRT) and Trans-Arterial Chemoembolization (TACE) in Hepatocellular Carcinoma and HCC, sponsored by Lahey Clinic. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Lahey Clinic · Phase 3, Interventional, and Treatment
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Lahey Clinic is the lead sponsor of 58 studies on the registry; 4 are open to participants now.
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Subjects with HCC are eligible for this trial. HCC is defined as having at least one of the following:
Patients must have adequate organ function within 2 weeks of enrollment.
Exclusion Criteria:
Radiation Therapy
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Procedure/Surgery - Chemoembolization Drug: Doxorubin
Procedure: Trans-Arterial Chemoembolization (TACE) · Drug: Doxorubin
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.
Also known as: Radiation Therapy
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
Also known as: Chemoembolization
This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
Also known as: Doxorubin bead therapy
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.
Time frame: 1 year post treatment
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.
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
To compare the number of further interventions between the SBRT and TACE arms.
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)
Complete pathologic response of lesions will be analyzed on the explant liver specimen after liver transplant. The pathology note will be consulted.
Time frame: 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.
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
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.
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
Overall survival will be compared in both arms at protocol specified time frames.
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
Compare the morbidity at 90 days post transplant between both arms.
Time frame: 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.
Time frame: Survival status to be captured 90 days post-transplantation (+/- 2 weeks)
| Milestone | Stereotactic Body Radiation Therapy (SBRT) | Trans-Arterial Chemoembolization (TACE) |
|---|---|---|
| Started | 4 | 5 |
| Completed | 0 | 0 |
| Not completed | 4 | 5 |
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.
No measurements were reported for this outcome.
To compare treatment related adverse events between both arms, SBRT and TACE.
No measurements were reported for this outcome.
To compare the number of further interventions between the SBRT and TACE arms.
No measurements were reported for this outcome.
Complete pathologic response of lesions will be analyzed on the explant liver specimen after liver transplant. The pathology note will be consulted.
No measurements were reported for this outcome.
Response of treated lesions will be analyzed at protocol specified time frames. The response rate between both treatment arms will be compared.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Overall survival will be compared in both arms at protocol specified time frames.
No measurements were reported for this outcome.
Compare the morbidity at 90 days post transplant between both arms.
No measurements were reported for this outcome.
Will assess the mortality of post-transplant patients between the two arms.
No measurements were reported for this outcome.
Collected over Baseline, During Treatment, post treatment follow-up visit, 3 Month, 6 Month, then every 3 months until 24 month time point.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Trans-Arterial Chemoembolization (TACE) | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Categorical(Participants) | Stereotactic Body Radiation Therapy (SBRT) | Trans-Arterial Chemoembolization (TACE) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 3 | 5 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Stereotactic Body Radiation Therapy (SBRT) | Trans-Arterial Chemoembolization (TACE) | Total |
|---|---|---|---|
| Mean | 65.8 ± 3.9 | 60.6 ± 7.6 | 62.8 ± 6.5 |
| Sex: Female, Male(Participants) | Stereotactic Body Radiation Therapy (SBRT) | Trans-Arterial Chemoembolization (TACE) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 4 | 5 | 9 |
| Race (NIH/OMB)(Participants) | Stereotactic Body Radiation Therapy (SBRT) | Trans-Arterial Chemoembolization (TACE) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 5 | 9 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Stereotactic Body Radiation Therapy (SBRT) | Trans-Arterial Chemoembolization (TACE) | Total |
|---|---|---|---|
| Canada | 1 | 1 | 2 |
| United States | 3 | 4 | 7 |
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