Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery (NCT NCT01899261)

Last Updated: 2022-11-29

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Within 3 months of SBRT

Results posted on

2022-11-29

Participant Flow

Participant milestones

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

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=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Child-Pugh Score 5	10 Participants n=5 Participants
Child-Pugh Score 6	7 Participants n=5 Participants
Child-Pugh Score 7	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 months of SBRT

Outcome measures

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 years

Cancer 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

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 years

Overall 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

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 years

Population: 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

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 events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 718-920-7750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place