Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery (NCT NCT01899261)
NCT ID: NCT01899261
Last Updated: 2026-04-20
Results Overview
The percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
COMPLETED
NA
20 participants
Within 3 months of SBRT
2026-04-20
Participant Flow
Participant milestones
| Measure |
Treatment (SBRT)
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Treatment (SBRT)
n=20 Participants
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
Age, Continuous
|
67 years
n=129 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=129 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=129 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=129 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=129 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=129 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=129 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=129 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=129 Participants
|
|
Child-Pugh Score
5
|
10 Participants
n=129 Participants
|
|
Child-Pugh Score
6
|
7 Participants
n=129 Participants
|
|
Child-Pugh Score
7
|
3 Participants
n=129 Participants
|
PRIMARY outcome
Timeframe: Within 3 months of SBRTThe percentage of patients who have severe treatment-related toxicity will be computed, along with exact 95% confidence intervals. Severe toxicity will be defined as grade 4 or 5 hepatic toxicity, thrombocytopenia, or gastrointestinal toxicity, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Outcome measures
| Measure |
Treatment (SBRT)
n=20 Participants
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
Severe Treatment-related Toxicity
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from study entry to death from Hepatocellular Carcinoma (HCC) progression, assessed up to 2 yearsCancer Specific Survival (CSS) was assessed in patients who were diagnosed with HCC and treated with liver SBRT as the percentage of patients with Cause-Specific Death from HCC. Patients alive at the end of the follow-up period were censored. Competing risk analysis was performed.
Outcome measures
| Measure |
Treatment (SBRT)
n=20 Participants
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
Cancer Specific Survival (CSS)
|
10 percentage of patients
|
SECONDARY outcome
Timeframe: Time from study entry to death from any cause, assessed up to 2 yearsOverall Survival, estimated using the Kaplan-Meier method, reflected the percentage of patients who were were diagnosed with HCC and started SBRT treatment and were still alive at the conclusion of the study.
Outcome measures
| Measure |
Treatment (SBRT)
n=20 Participants
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
Overall Survival (OS)
|
65 percentage of patients
|
SECONDARY outcome
Timeframe: From date of first treatment dose to the first date of objective local progressive disease as defined by RECIST criteria, assessed up to 2 yearsPopulation: 2 subjects with local progression after Stereotactic Body Radiation Therapy (SBRT)
Time to Local progression (TTLP) of treated lesions in HCC patients after liver SBRT treatment was evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST). For patients who died from the study disease without progression of the radiated lesion, time to local progression was censored at the date of death. For patients not known to have died as of the data cut-off date, and who did not have locally progressive disease, time to local progression was censored at the last progression-free disease assessment.
Outcome measures
| Measure |
Treatment (SBRT)
n=2 Participants
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
Time to Local Progression (TTLP) of Treated Lesions
|
6 months
Interval 1.0 to 11.0
|
Adverse Events
Treatment (SBRT)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (SBRT)
n=20 participants at risk
Patients undergo SBRT every other day over 2 weeks (5 fractions total) in the absence of unacceptable toxicity.
Stereotactic Radiosurgery: Undergo SBRT
|
|---|---|
|
General disorders
Fatigue
|
15.0%
3/20 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
10.0%
2/20 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
2/20 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Number of events 1
|
Additional Information
Dr. Nitin Ohri
Montefiore Medical Center and Albert Einstein College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place