Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant (NCT NCT03960008)
NCT ID: NCT03960008
Last Updated: 2024-08-28
Results Overview
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.
TERMINATED
PHASE3
9 participants
1 year post treatment
2024-08-28
Participant Flow
Participant milestones
| Measure |
Stereotactic Body Radiation Therapy (SBRT)
Radiation Therapy
Stereotactic Body Radiation Therapy (SBRT): 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/Surgery - Chemoembolization Drug: Doxorubin
Trans-Arterial Chemoembolization (TACE): 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
Doxorubin: This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy (SBRT) vs Trans-Arterial Chemoembolization (TACE) as Bridge to Transplant
Baseline characteristics by cohort
| Measure |
Stereotactic Body Radiation Therapy (SBRT)
n=4 Participants
Radiation Therapy
Stereotactic Body Radiation Therapy (SBRT): 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)
n=5 Participants
Procedure/Surgery - Chemoembolization Drug: Doxorubin
Trans-Arterial Chemoembolization (TACE): 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
Doxorubin: This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
60.6 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year post treatmentPopulation: Data has not been collected and therefore not analyzed for this outcome.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each treatment, 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatmentPopulation: Data has not been collected and therefore not analyzed for this outcome
To compare treatment related adverse events between both arms, SBRT and TACE.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks post treatment, 2 months post treatment, 5 months post treatment, every 3 months until 24 months post treatmentPopulation: Data has not been collected and therefore not analyzed for this outcome.
To compare the number of further interventions between the SBRT and TACE arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Review of pathology report after liver transplantPopulation: Data has not been collected and therefore not analyzed 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 2 months post-treatment, 5 months post-treatment, every 3 months thereafter until 2 years post treatmentPopulation: Data has not been collected and therefore not analyzed 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatmentPopulation: Data has not been collected and therefore not analyzed 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, during treatment, 2 months post-treatment, 5 months post-treatment, every 3 months until 24 months post treatmentPopulation: Data has not been collected and therefore not analyzed for this outcome
Overall survival will be compared in both arms at protocol specified time frames.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Disease status to be captured 90 days post-transplantation (+/- 2 weeks)Population: Data has not been collected and therefore not analyzed for this outcome
Compare the morbidity at 90 days post transplant between both arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Survival status to be captured 90 days post-transplantation (+/- 2 weeks)Population: Data has not been collected and therefore not analyzed for this outcome.
Will assess the mortality of post-transplant patients between the two arms.
Outcome measures
Outcome data not reported
Adverse Events
Stereotactic Body Radiation Therapy (SBRT)
Trans-Arterial Chemoembolization (TACE)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Julia Roache, Manger, Research Programs
Lahey Hospital & Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place