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

Early Phase 1

Completed

Conditions: Hepatocellular Carcinoma (HCC)

Interventions: Combination Product: Stereotactic Body Radiation Therapy (SBRT)

Registration Number: NCT01247298

Lead Sponsor: University of Alabama at Birmingham

Brief Summary: This investigational study will evaluate if using a combination of TACE along with high dose SBRT would show improvement in local control in patients with Hepatocellular Carcinoma.

Detailed Description: Primary objectives of this research

1. Evaluate the safety of a combination of TACE and high dose SBRT

2. Measure time to progression (TTP) and local recurrence rate of HCC treated with a combination of TACE \& SBRT.

Secondary objectives of this research

1. Assess failure patterns and survival of patients treated with TACE \& SBRT.

2. Analyze dose volume characteristics that influence Radiation Induced Liver Disease (RILD) among patients treated with a combination of TACE and SBRT.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 17

Inclusion Criteria

Diagnosis

Patients meeting all the following criteria will be considered for enrollment:

Pathologically confirmed HCC -OR
HCC greater than 2 cm with classic radiographic findings on 2 separate testing modalities, or an HCC greater than 2 cm with a serum alpha feto-protein greater than 200.

Lesions:

Single liver lesion: measuring 3 cm to ≤ 8 cm*.

Multiple liver lesions: ≤ 3 liver lesions, none measuring over 5 cm, provided all lesions are considered for TACE.
Lesions <3 cm if they are in an unfavorable location for ablation† *The size criteria of hepatic lesions are also subjected to the dose volume constraints for radiotherapy, as described below.

Patient

Patient deemed to not candidate or should have refused liver-transplant, surgery or RFA.
Patient must be a candidate and receive TACE.
ECOG (Eastern Cooperative Oncology Group) Zubrod Performance Scale = 0-1.
Age > 19
Patient should not be pregnant. Women of childbearing potential and male participants must practice adequate contraception.

Adequate hematological profile and adequate liver functions. Signed informed consent document

Imaging studies completed at least 60 days prior to study entry. Evaluated by radiation oncologist within 2 weeks prior to study entry.

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:

Prior invasive malignancies
Prior radiotherapy to the liver or surrounding areas.
Systemic therapy using any chemotherapy and/or targeted agents given within 2 weeks prior to TACE, during RT, and / or within 3 weeks following RT
Severe medical co-morbidities
INR (international normalized ratio) > 2 times upper level normal
Uncontrolled or symptomatic clinical ascites
Major surgical procedure within 3 weeks prior to study entry.
History of hypersensitivity to chemotherapy agents, contrast material.
Pregnancy, breast-feeding or planning to become pregnant.
Treatment with any investigational product in the last 4 weeks before study entry.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Patients of Reproductive Potential The patient must not be pregnant or breast-feeding at enrollment in the study. Absence of pregnancy must be demonstrated by serum or urine testing prior to enrollment into the study.

Female patients of child bearing potential (i.e., ovulating, premenopausal, not surgical sterile) must use a medically accepted contraceptive regimen. Male patients must agree to use a medically approved method of contraception.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiation Therapy (SBRT)	Stereotactic Body Radiation Therapy (SBRT)	Patients will receive stereotactic body radiation therapy (SBRT) which is 3 radiation treatments at 15 Gy, for a total of 45 Gy. Patients will be given Trans-Arterial Chemoembolization (TACE), prior to enrollment. (TACE is not performed as part of this clinical study, even though it is part of the inclusion criteria.)

Primary Outcome Measures

Name	Time	Method
Safety of a Combination Therapy	Baseline to 45 day after completing combination treatment.	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.
Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.	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.
Local Recurrence Rate	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Overall Survival	up to 2 years after treatment completed	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.
Percentage of Participants With Local Failure Patterns	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