Trial Outcomes & Findings for Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma (NCT NCT01020812)

Results Overview

Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

12 months

Results posted on

2016-07-27

Participant Flow

Participant milestones

Participant milestones
Measure	SBRT and TACE SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	SBRT and TACE SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
Overall Study Physician Decision	1
Overall Study Withdrawal by Subject	1
Overall Study Protocol Violation	1

Baseline Characteristics

Combination SBRT With TACE for Unresectable Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Body Radiotherapy (SBRT) n=8 Participants SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
Age, Continuous	67.1 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All patients who completed treatment

Freedom from local progression is defined as the time from start of treatment until the first occurrence of local progression. Local progression is defined as progression in the treated lesion according to the RECIST criteria. Progression outside the treated lesion and/or death will be considered as competing risks. The data was analyzed in a competing risk model with death as a competing risk. The outcome reported is the cumulative incidence at 12 months.

Outcome measures

Outcome measures
Measure	SBRT and TACE n=8 Participants SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
Freedom From Local Progression of TACE and SBRT at 12 Months	0.286 proportion of participants Interval 0.031 to 0.636

SECONDARY outcome

Timeframe: 18 months

Population: All patients who completed the treatment

Progression free survival is defined as the time from the start of treatment until the first progression or death. Progression will be defined as either local progression, disease occurring elsewhere in the liver, extrahepatic progression or clinical deterioration attributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.

Outcome measures

Outcome measures
Measure	SBRT and TACE n=8 Participants SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
To Determine the Progression-free Survival of TACE and SBRT at 18 Months	0.400 survival probability at 18 months

SECONDARY outcome

Timeframe: 18 months

Population: All patients who completed treatment

Overall survival is defined as the time from the start of treatment until death from any cause.

Outcome measures

Outcome measures
Measure	SBRT and TACE n=8 Participants SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
To Determine the Overall Survival of TACE and SBRT at 18 Months	0.857 probability

SECONDARY outcome

Timeframe: 18 months

Time to progression free survival is defined as the time from randomization until either death or progression of disease. The median survival was calculated using a Kaplan Meier algorithm.

Outcome measures

Outcome measures
Measure	SBRT and TACE n=8 Participants SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
Median Progression Free Survival	12 months Interval 3.0 to 20.0

Adverse Events

SBRT and TACE

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SBRT and TACE n=8 participants at risk SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure. Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction TACE: Standard of Care SBRT: Standard of Care
General disorders Fatigue	25.0% 2/8 • Number of events 2 • 25 months. The adverse events for recorded for the entire study period.
Hepatobiliary disorders Hepatobiliary disorder	12.5% 1/8 • Number of events 2 • 25 months. The adverse events for recorded for the entire study period.
Hepatobiliary disorders transiminitis	12.5% 1/8 • Number of events 2 • 25 months. The adverse events for recorded for the entire study period.
Gastrointestinal disorders colonic ulcer	12.5% 1/8 • Number of events 1 • 25 months. The adverse events for recorded for the entire study period.
Hepatobiliary disorders bili increase	12.5% 1/8 • Number of events 2 • 25 months. The adverse events for recorded for the entire study period.

Additional Information

Daniel T Chang

Stanford University

Phone: 650-723-6171

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place