Trial Outcomes & Findings for A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma (NCT NCT01247298)

Last Updated: 2017-08-21

Results Overview

Evaluate the safety of a combination of TACE and high dose SBRT. Patients were evaluated for toxicity during their follow-up exams every 3 months for 2 years while participating in this study. Patients were also instructed to notify the PI between visits if any related toxicity issues occurred.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Baseline to 45 day after completing combination treatment.

Results posted on

2017-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	TACE + SBRT Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TACE + SBRT n=17 Participants Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	5 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 45 day after completing combination treatment.

Population: All enrolled patients were analyzed.

Outcome measures

Outcome measures
Measure	TACE + SBRT n=17 Participants Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Safety of a Combination Therapy	0 participants

PRIMARY outcome

Timeframe: Baseline to up to 2 years after treatment completed

Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months until complete response or progression. This will be measured by tumor progression and/or death on follow-up imaging from completion of treatment.

Outcome measures

Outcome measures
Measure	TACE + SBRT n=17 Participants Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.	25.6 months Interval 13.2 to 33.5

PRIMARY outcome

Timeframe: Baseline to up to 2 years after treatment completed

Evaluate the number of patients with local recurrence. Patient will be asked to visit their study doctor for follow-up exams every 3 months for 2 years while participating in this study.Patient will be asked to visit their study doctor for follow-up exams and imaging (CT or MRI) every 3 months. This will be measured by number of patients with recurrence on their follow-up imaging.

Outcome measures

Outcome measures
Measure	TACE + SBRT n=17 Participants Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Local Recurrence Rate	7 participants

SECONDARY outcome

Timeframe: up to 2 years after treatment completed

Population: Survival analysis was performed for all patients.

Assess overall survival (OS) of patients treated with TACE \& SBRT. This is assessed by the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease are still alive.

Outcome measures

Outcome measures
Measure	TACE + SBRT n=17 Participants Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Percentage of Participants With Overall Survival	82.3 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to 2 years after treatment completed

Assess local failure patterns of patients treated with TACE \& SBRT. This is assessed by the percentage of patients where recurrence occurred

Outcome measures

Outcome measures
Measure	TACE + SBRT n=17 Participants Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. Eligible patients will receive 3 radiation treatments at 15 Gy, for a total of 45 Gy. Trans- Arterial Chemoembolization: TACE involves accessing the major feeder artery to the liver tumor using a catheter passed through the femoral artery in the groin.
Percentage of Participants With Local Failure Patterns	41.2 percentage of participants

Adverse Events

TACE + SBRT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rojymon Jacob, MD

University of Alabama at Birmingham (UAB)

Phone: 205-975-9704

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place