Clinical trial NCT01247298: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
Official title: RAD 0902: A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma (HCC)
Keywords: Hepatocellular Carcinoma (HCC)
Trans-Arterial Chemobolizaion (TACE)
Radiation Induced Liver Disease (RILD)
Stereotactic Body Radiation Therapy (SBRT)
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

1. Prior invasive malignancies
2. Prior radiotherapy to the liver or surrounding areas.
3. 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
4. Severe medical co-morbidities
5. INR (international normalized ratio) \> 2 times upper level normal
6. Uncontrolled or symptomatic clinical ascites
7. Major surgical procedure within 3 weeks prior to study entry.
8. History of hypersensitivity to chemotherapy agents, contrast material.
9. Pregnancy, breast-feeding or planning to become pregnant.
10. Treatment with any investigational product in the last 4 weeks before study entry.
11. 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.

Primary outcomes:
measure: Safety of a Combination Therapy
timeFrame: Baseline to 45 day after completing combination treatment.
measure: Median Progression Free Survival (PFS) Treated With a Combination of TACE & SBRT.
timeFrame: Baseline to up to 2 years after treatment completed
measure: Local Recurrence Rate
timeFrame: Baseline to up to 2 years after treatment completed
Secondary outcomes:
measure: Percentage of Participants With Overall Survival
timeFrame: up to 2 years after treatment completed
measure: Percentage of Participants With Local Failure Patterns
timeFrame: Baseline up to 2 years after treatment completed
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham/Department of Radiation Oncology
name: Rojymon Jacob, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham Department of Hepatobiliary Surgery
name: Derek A. Dubay, MD
role: PRINCIPAL_INVESTIGATOR
References: