Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer (NCT NCT03812289)
NCT ID: NCT03812289
Last Updated: 2025-03-07
Results Overview
"Transplant eligible" means transplanted within 1 year or having localized disease control that meets Milan criteria at 1-year post-SBRT. Reported with 95% exact confidence interval.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs first
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Treatment (SBRT)
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Overall Study
STARTED
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9
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Overall Study
COMPLETED
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9
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer
Baseline characteristics by cohort
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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6 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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3 Participants
n=99 Participants
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Age, Continuous
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58 years
n=99 Participants
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Sex: Female, Male
Female
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2 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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7 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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7 Participants
n=99 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
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Region of Enrollment
United States
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9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From first SBRT dose to time of disease progression, transplantation, or 1 year after last SBRT dose (Day 374), whichever occurs firstPopulation: Efficacy analysis set, comprising participants who have received at least 85% of the prescribed SBRT dose
"Transplant eligible" means transplanted within 1 year or having localized disease control that meets Milan criteria at 1-year post-SBRT. Reported with 95% exact confidence interval.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Proportion of Participants Who Are Transplant Eligible 1 Year Following SBRT
|
66.7 percentage of participants
Interval 29.9 to 92.5
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SECONDARY outcome
Timeframe: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs firstPopulation: Efficacy analysis set
Local control is defined as the absence of progressive disease within or at the planning target volume (PTV) margin.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Localized Control Rate
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100.0 percentage of participants
Interval 66.4 to 100.0
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SECONDARY outcome
Timeframe: From first SBRT dose to time of intrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.Population: Efficacy analysis set
Intrahepatic progressive disease is defined as development of intrahepatic recurrent or new disease within any section of the liver, including the PTV.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Incidence of Intrahepatic Progressive Disease
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0.0 percentage of participants
Interval 0.0 to 33.6
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SECONDARY outcome
Timeframe: From first dose of SBRT to time of extrahepatic disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.Population: Efficacy analysis set
Extrahepatic progressive disease is defined as progressive disease outside of the liver.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Incidence of Extrahepatic Progressive Disease
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0.0 percentage of participants
Interval 0.0 to 33.6
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SECONDARY outcome
Timeframe: From first SBRT dose to time of disease progression, transplantation, death, or 2 years after last SBRT dose (Day 739), whichever occurs first.Population: Efficacy analysis set
Measured and reported with 95% confidence interval.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Proportion of Participants That Proceed to Transplantation
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66.7 percentage of participants
Interval 29.9 to 92.5
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SECONDARY outcome
Timeframe: From first SBRT dose to time of death or 2 years after last SBRT dose (Day 739), whichever occurs first.Population: Efficacy analysis set
Reported with median survival and 95% confidence interval, if available.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Overall Survival
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13.7 months
Interval 4.1 to
Upper bound for 95% confidence interval was not estimable due to an insufficient number of participants with death events.
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SECONDARY outcome
Timeframe: From first SBRT dose to 3 months after last SBRT dose (Day 100)Population: Safety analysis set
Non-classic RILD is defined as grade 4 aspartate aminotransferase or alanine aminotransferase elevation, or an increase in Child-Pugh score of ≥ 2 within 1 week to 3 months after completing SBRT. Will be estimated along with an exact confidence interval.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Incidence of Non-classic Radiation-induced Liver Disease (RILD)
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0.0 percentage of participants
Interval 0.0 to 33.6
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SECONDARY outcome
Timeframe: From 1 week (Day 16) to 3 months (Day 100) after completing SBRTPopulation: Safety analysis set
Liver toxicity is assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be estimated along with an exact confidence interval.
Outcome measures
| Measure |
Treatment (SBRT)
n=9 Participants
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Incidence of Liver Toxicity Within 1 Week to 3 Months After SBRT.
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11.1 percentage of participants
Interval 0.3 to 48.2
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OTHER_PRE_SPECIFIED outcome
Timeframe: From screening to death or 2 years after last SBRT dose, whichever occurs first.Summary of QoL over time. No hypothesis testing is planned for QoL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From screening to death or 2 years after last SBRT dose, whichever occurs first.Summary of QoL over time. No hypothesis testing is planned for QoL.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At transplantationDescriptive statistical analysis of the proportion of efficacy set participants with histopathologic changes in irradiated tumor sites (of explanted livers) relative to uninvolved liver tissue.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (SBRT)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (SBRT)
n=9 participants at risk
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Injury, poisoning and procedural complications
Hip fracture
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11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
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11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Metabolism and nutrition disorders
Acidosis
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11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Hepatobiliary disorders
Hepatic failure
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11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Infections and infestations
Sepsis
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11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Nervous system disorders
Encephalopathy
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22.2%
2/9 • Number of events 3 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Other adverse events
| Measure |
Treatment (SBRT)
n=9 participants at risk
Patients undergo Stereotactic Body Radiation Therapy (SBRT), with 5 fractions planned for study days 1, 3, 5, 7, and 9, and a total dose of 40, 35, or 30 gray depending on normal organ constraints being met.
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|---|---|
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Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Gastrointestinal disorders
Nausea
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11.1%
1/9 • Number of events 1 • Serious and Other Adverse Events were assessed for up to 3.5 months. However, All-Cause Mortality was assessed for up to Day 739 (2 years after last SBRT dose).
AEs will be evaluated and graded per NCI CTCAE v5.0 from the time the participant signs the consent form to 3 months following SBRT.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place